Probiotic in pre- and/or postoperative period

FIELD: medicine.

SUBSTANCE: what is presented is the use of the strain Lactobacillus johnsonii in preparing a probiotic composition for prevention of postoperative abdominal and pelvic infections caused by pelvic liquid accumulation, anastomosis leakage, or caused by bacterial translocation.

EFFECT: colonic L Johnsonii Lai colonisation in the patients underwent colectomy for colorectal adenocarcinoma.

11 cl, 1 dwg, 1 tbl, 2 ex

 

The present invention generally relates to the field of power, more specifically to the use of probiotics in the diet and, in particular, to the use of probiotics in the preoperative and postoperative period.

In 1907, the Russian scientist Mechnikov (1845-1919), working at the Pasteur Institute in Paris, published a paper demonstrating a beneficial effect of lactic acid bacteria contained in yogurt. Mechnikov put forward the hypothesis that a high concentration of lactobacilli in the intestinal flora may be important for the health and longevity of people (Metchnikoff EM, et al., The prolongation of life: optimistic studies. London: Heinemann 1907; 161-183).

Since that time, has not been proposed by any other group of bacteria responsible for so many different favorable effects to the same extent as lactic acid bacteria, mainly lactobacilli and bifidobacteria. They provide: stimulyatsiyu phagocytosis of viable Salmonella by macrophages (G Hatcher et al., J.Dairy.Sci. 1993; 76: 2485-2492); strengthening education IgA in intestinal secretions (Perdigon G, et al., J.Food.Proct. 1990; 53: 404-410), education antimicrobial substances (Shahani KM, et al., Am.J.CIin.Nutr. 1980; 33: 2448-2457; Silvia M, et al., Antimicr.Agen. Chemother. 1987; 31: 1231-1233); inhibition of adhesion and invasion enterovirulent bacteria (Bemet MF, et al., Gut 1994; 35: 483-489) and decrease intestinal permeability to macromolecules in rotavirus-inducido is authorized diarrhea (Isolauri E, et al., Pediatr Res 1993; 33: 548-553). Bacteria Lactobacillus has also been successfully used in the treatment of recurrent colitis caused by Clostridium difficile (Gorbach SL, et al., Lancet 1987; 2: 1519).

These favorable properties do not apply to all strains of Lactobacillus and Bifidobacteria. The lactic acid bacteria showing favorable biological activity, is considered as probiotics. However, not all probiotics have the same type of favorable biological activity. One example of Lactobacillus strains belonging to the group of probiotics, is the organism Lactobacillus johnsonii (Lal) (Nestle. Lactobacillus johnsonii (Lal) Scientific Overview; 1999). This strain was selected a few years ago from the intestinal flora of human research center "Nestle" in Lausanne.

Bacteria Lal can be considered as a probiotic, because strain:

is not pathogenic;

- remains viable upon reaching the small intestine or colon;

shows good adhesion to the membrane of the mucosa of the colon;

- is a natural component of the intestinal flora of man.

In addition, the study demonstrated that bacterial strain Lal has some other favorable properties, namely:

- inhibition of attachment of several enteropathogenic bacteria (E.Coli and Salmonella ssp spp) to the cells of the human intestine in vitro;

- prativadi Anya effects and inhibition of invasive species E.Coli;

- impact on the prevention of disease caused by N. Pylori;

- stimulation of immune protection;

stimulation of phagocytosis;

- stimulation of education IgA;

- antagonism colonization of Clostridium perfinngens.

The strain of bacteria Lal currently used in products from fermented milk (product range LC1 "Nestle"), which are widely offered on the market in Europe, as a new concept of healthy eating. No side effects have not been documented when using all layers of the population, and, thus, the probiotic strain Lal can be considered as safe.

It has been hypothesized that the intake of probiotic bacteria in General, affects the composition of the intestinal microflora by reducing the number of pathogens in favor of nematogens. These phenomena can modulate immune and inflammatory responses and function of the intestine (Llopis, M, et al., Gut 2005 54: 955-959).

Experimental data showed that modulation using Lactobacillus plantarum functions of the enteric mucosa and microflora reduces septic morbidity and mortality among the animals. It was shown that the use of mixture of probiotics are more effective than antibiotics for the treatment of inflammation pocket ileum in humans (Gionchetti, Paolo et al., Gastroenterology 2003, 124: 1202-9).

Although the positive effects of probiotics, as one of the aspects of modern food today, in normal conditions, has received wide recognition, has never been proposed to use probiotics as part of nutrition in preclinical and/or poliklinicheskoi environment. One reason for this may be that, as we all know, surgery should be performed under sterile conditions. It seems that the use of bacteria in the preparation for surgery and for short period after surgery is contrary to recommended sterility.

Usually, and exactly the opposite of healthy people in normal life, people in the preoperative and poliklinicheskoi environment are under significant stress, heavy antibiotic treatment and may suffer from a weakening of the immune system and/or are in serious danger of colonization of pathogenic and antibiotic-resistant bacteria, which appear more and more often in periodically sterilized premises, such as hospitals.

Therefore, preclinical and/or policlinicheskiy period cannot be compared with normal living conditions.

Since, however, patients undergoing surgery are at high risk of developing infections, for example, due to intraoperative contamination of the intestinal content and the occurrence of bacterial translocation would be desirable to have available a method, in order to prevent and/or reduce such complications and postoperative sepsis.

Considering existing state of the art the present invention was to provide a method of preparation of the patient, so good, as far as possible, for the special preoperative and/or postoperative period.

This problem is solved by the application in accordance with paragraph 1 of the claims.

In particular, the present inventors unexpectedly found that probiotic or probiotic mixture can be used and the production of nutritional compositions or drugs acting on the colon in the preoperative and postoperative period.

Probiotic for the purpose of the present invention is a microorganism, dead or alive, or part of the above, which, being put in adequate amounts, benefit the health of the recipient. Preferably, probiotics are live microorganisms, which, when put in adequate amounts, benefit the health of the recipient.

Nutritional composition for the purpose of the present invention is a nutritionally balanced ready-made form that contains an adequate proportion of macro - and micronutrients. Persons skilled in this field will understand that the composition of the nutrient SB is laserowej final form will depend on many factors, such as age, sex and condition, the condition of the patient to be treated. However, persons skilled in this field will be able to determine the composition prepared properly.

In the framework of the present invention, the way in which probiotics act on the colon, nothing special is limited. If you use non-viable probiotics, they can act on the distal small intestine or proximal colostomy, for example, by release of a significant number of bacterial molecular patterns that can stimulate the immune response and promote a state of homeostatic modulation of the mucosa of the distal intestine. Thus, bacterial products or conservative molecules will mainly interact with cellular receptors of the recipient on the epithelial or dendritic cells slimy compartment (S.Rakoff-Nahoum et al., Cell. 2004 118: 229-241).

In contrast, live probiotics can act on the colon by passing through it. Possible effects produced viable probiotics, passing through the colon, can occur because of the ability of probiotics to grow and, consequently, to compete for available living space in the distal intestinal environment and samastaiatelna bacteria; in addition or alternatively, probiotics (because they remain metabolically active) can prevent excessive development of pathogens due to metabolic products, such as fatty acids with short-chain, and release of bioactive molecules that may be bacteriostatic or bactericidal activity against other bacteria. Moreover, live bacteria and molecules released as a result of their metabolic activity or natural cell death, have the ability to interact with expressed on the surface of the mucosal immune molecules recipient and, thus, to stimulate an immune response or induce cytoprotective response of mucosal cells.

Preferably, however, probiotics reach the colon alive and colonise it. Thus, they create a permanent presence and can cause much more pronounced effect. In particular, probiotics, which create a local presence through colonization, are effective in changing environmental situation in the colon through its metabolic activity.

Thus, in one preferred embodiment of the present invention probiotics act by attempting to reach the colon alive, in particular through the colonization of the colon is Eski.

If probiotics colonise the colon, they preferentially colonise the lumen of the colon and mucous surfaces. Thus, they can produce a more pronounced effect.

The investigation of the effect of probiotics in the colon is that non-infectious diarrhea can be prevented and/or treated nutrient composition or the medicinal product is manufactured by applying the present invention.

Another consequence of this effect on the colon is that postoperative abdominal and pelvic infections, caused by accumulation of fluid in the pelvic region against leakage at the anastomosis or due to bacterial translocation, can be prevented nutrient composition or the medicinal product is manufactured by applying the present invention.

Another consequence of this effect on the colon lies in the fact that gastrointestinal symptoms, on the background of global changes in intestinal microbial ecology and metabolic activity of the microbiota, preferably, infectious or toxicogenic diarrhea can be prevented and/or mitigated nutrient composition or the medicinal product is manufactured by applying the present invention. I believe that disruption of the normal flora of the gastro-intestinal t the act, especially after the use of antibiotics and/or surgery of the colon, predispose patients to colonization .difficile. Nutrient composition or drug of the present invention containing the selected probiotics, are able to colonize the colon, in particular the lumen of the colon and/or mucous surface, can restore the balance in the altered gastrointestinal flora and thus to protect against colonization or excessive development of potentially pathogenic bacteria.

Another consequence of this effect on the colon lies in the fact that gastrointestinal infections, preferably, nosocomial gastrointestinal infections can be prevented or treated nutrient composition or the medicinal product is manufactured by applying the present invention. Such gastrointestinal infections are often responsible for the occurrence of diarrhoea, which, therefore, can be prevented and/or treated in accordance with this invention.

Moreover, the nutritional composition or the medicinal product is manufactured according to the present invention, are mainly to be used to prevent nosocomial colonization of methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci and other sustainable is x to antibiotics microorganisms in the nosocomial environment.

In particular, the present invention, probiotics can be used in the manufacture of a nutritional composition and/or drugs for modulating, in particular the amplification of the inflammatory response, in particular during the healing process. This action products obtained by applying the present invention, can be achieved, for example, the promotion of education in the mucous secreted antibodies.

Nutrient composition and/or the medicinal product is manufactured according to the present invention, can be used to modulate the immune system and/or to promote education in the mucous secreted antibodies.

Type suitable for the present invention probiotics nothing specific is not limited. Apply any known probiotic.

However, preferably, the probiotic was selected from the group consisting of Bifidobacterium, Lactobacillus, Streptococcus and Saccharomyces or mixtures thereof; more preferred is a probiotic selected from the group consisting of Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus johnsonii, Lactobacillus plantarum, Lactobacillus salivarius, Streptococcus faecium, Saccharomyces boulardii and Lactobacillus reuteri or mixtures thereof; and most preferably, selected probiotic selected from the group consisting of Lactobacillus johnsonii Lal (CNCM 1-1225), Bifidobacterium longum (CNCM 1-2170), Bifidobacterium lactis Bb12 (German Culture Collecion: DSM20215), (Lactobacillus paracasei (CNCM 1-2116, CNCM 1-1292)), Lactobacillus rhamnosus GG, Streptococcus faecium SF 68, or mixtures thereof.

In one embodiment of the present invention nutritional composition and/or medicine, in addition, contain additional non-viable probiotic bacteria and/or material derived from probiotics. The material obtained from probiotics, can be any material obtained from the probiotics, such as, for example, the cellular fraction or compound or group of compounds isolated from probiotics; or may be material, which was produced with the help of probiotics, such as culture medium or part of it, which was cultivated probiotics, or product that has been modified using probiotics; or a mixture of the above.

Preferably, the nutritional composition and/or the medicinal product is manufactured according to the present invention optionally contain an enzymatic substrate for probiotics. It was found that it supports the viability of probiotics, for example, during storage.

In one embodiment of the present invention the composition and/or the medicinal product is manufactured according to the present invention optionally contain one or more prebiotic. For the purposes of the present invention prebiotics are neperevershenymy components is nami food beneficial effect on the recipient selective stimulation of growth and/or activity of one or more bacterial species in the colon.

Prebiotics have the advantage that they support the growth of beneficial bacteria in the colon of the patient. In addition, they support the viability of live probiotics present in the composition and/or medicinal product, manufactured according to the present invention, both during storage and after ingestion by the patient.

The patient may be human or animal. Preferred animals are Pets and livestock.

In one embodiment of the present invention nutritional composition and/or the medicinal product is manufactured according to the present invention, contain probiotics in amounts of about 105-1011CFU/ml, preferably about 106-109CFU/ml, most preferably about 107-108CFU/ml Clear, however, that the optimal number of probiotics is determined by the medical staff, because it depends on many factors, such as, for example, race, age, gender, condition, body weight of the patient, as well as the nature of the product. Usually, medicines will contain higher quantities of probiotics than nutrient composition. In General, any number of probe the ticks will produce a beneficial effect.

The composition of the present invention provides in one embodiment an additional source of carbohydrates, a source of lipids and/or the source of proteins.

It should be understood that the composition of the present invention is a nutritional composition and/or the medicinal product is manufactured according to the present invention.

Nutrient composition and/or the drug may include a source of lipids.

Preferably, the source of lipids provides from about 18% to about 50% of the energy of the nutritional composition, more preferably from about 25% to about 35% of the total energy of the nutritional composition, most preferably about 30% of the total energy of the composition.

The source of lipids may include medium chain triglycerides (medium chain triglycerides (MCT), for example, to the level of 20% of the total lipid mass. Such medium chain triglycerides are easily absorbed and metabolized seriously ill, patients with catabolic disorder. In the preferred embodiment the source of medium chain triglycerides is a fractionated coconut oil.

Lipid profile may also contain a mixture of long-chain triglycerides. Suitable sources of long chain triglycerides are canola oil, corn oil, soy lecithin and residual milk fat. The source of lipids may also contain inresidence fatty acids. Preferably, the source of lipids contains by weight from about 15% to about 30% polyunsaturated fatty acids, for example about 20% by weight of polyunsaturated fatty acids.

Lipid profiles containing long-chain triglycerides, calculated to have a polyunsaturated fatty acid omega-6 (n-6) and omega-3 (n-3) ratio from about 1:1 to 10:1. Preferably, the ratio of fatty acids of n-6 to n-3 is from about 5:1 to about 9:1, for example about 7:1. The proposed ratio of n-6:n-3 is designed to reduce the immune suppression associated with high concentration of omega-3 fatty acids, and adequate provision of essential fatty acids. In one embodiment, the composition includes a ratio of omega-6 to omega-3, equal to 7.7:1.

The source of lipids, preferably, has a high content of monounsaturated fatty acids. In particular, the source of lipids includes at least about 40% by weight of monounsaturated fatty acids. Preferably, the source of lipids includes from about 45% to about 65% by weight monounsaturated fatty acids; for example, about 55 mass %.

The source of lipids, preferably, has a share of saturated fatty acids is less than about 35% by weight; including medium chain triglycerides. More preferably, the source of lipids includes less than about 30 mass % saturated the IRNA acids.

Suitable sources of lipids include sunflower oil with high oleic acid safflower oil high oleic acid sunflower oil, safflower oil, rapeseed oil, soybean oil, olive oil, canola oil, corn oil, peanut oil, rice bran oil, fat, butter, hazelnut oil and structured lipids. Fractionated coconut oil is a suitable source of medium chain triglycerides.

The source of lipids can also contain vitamin E, preferably at least about 30 mg of vitamin E per 100 g source of lipids.

Nutrient composition and/or the drug can include a source of carbohydrates.

The source of carbohydrates, preferably, contains maltodextrin, corn syrup, corn starch, modified starch, or sucrose, or fructose, or mixtures thereof. The source of carbohydrates, preferably provides at least about 15%, preferably, about 20%-40% of the total calories of the composition, or from about 40% to about 65% of the energy of the nutritional composition; in particular, from about 50% to about 60% of the energy of the nutritional composition. For example, the source of carbohydrates can provide about 54% of the energy of the composition.

If necessary, the nutrient composition and/or dosage is the tool may not contain lactose.

For example, in order to avoid diarrhea, the composition may also contain cellulose, preferably in a quantity of at least 8 g/l, most preferably in a quantity of at least 14 g/L.

Therefore, the nutrient composition and/or drug, preferably, further include a source of soluble prebiotic fibers. Prebiotic fibers are fibers that have a positive effect on the recipient selective stimulation in colon growth and/or activity of bacteria that potentially can improve the recipient's health. Suitable soluble, prebiotic fiber include fructo-oligosaccharides (FOS) and inulin. Suitable extracts of inulin can be purchased from Orafti SA of Tirlemont 3300, Belgium under the trade mark "Raftiline". Similarly, suitable fructo-oligosaccharides can be purchased from Orafti SA of Tirlemont 3300, Belgium under the trade mark "Raftilose".

Preferably, FOS and inulin provide in the ratio from about 60:about 40 to about 80:about 20, most preferably about 70:about 30. Other possible fiber include gums, such as guar gum, xanthan gum, xylooligosaccharide, gum Arabic, pectin, gum acacia, resistant starch, dextrans, or a mixture thereof. Preferably, the fibers should not call what to saturation.

Reported that soluble prebiotic fibers activate the growth of bifidobacteria in the gastrointestinal tract and, in certain circumstances, prevent or reduce the growth of pathogens, such as Clostridiae. In addition, it was reported that the promotion of the growth of bifidobacteria has various other beneficial effects. Also, during the fermentation of fiber in the colon are formed short-chain fatty acids. These fatty acids are the fuel for intestinal cells.

Soluble prebiotic fibers are preferably present in a quantity sufficient to provide from about 4 to about 9 g of soluble amenable to fermentation of fibers to the patient per day. Therefore, prebiotic fibers may be present in an amount of from about 6 g to about 12 g per 1000 kcal. Alternative embodiments include a mixture of prebiotic fibers in an amount of 9 g or less, for example 4 g of the mixture.

If necessary, nutritional support may also contain a source of insoluble fiber. Suitable sources of insoluble fiber is fiber shell legumes and grains; for example, fiber shell peas, fiber shell oats, fiber membranes of barley and fiber shell soybeans.

Similarly, osmollnosti the nutritional composition may be adjusted scheduled for the Noah goals, for example, to avoid diarrhea, in particular, to be less than 500 mOsm, more preferably be less than 300 mOsm, for example osmollnosti from about 100 to 250 mOsm. Squarematerial products usually have a higher osmollnosti than unflavored products.

Nutrient composition and/or the drug can include a source of protein.

The protein source may include at least about 50 wt.% whey protein, which, preferably, should be partially hydrolyzed. Whey protein used to obtain the hydrolysate may be commercially available source of whey protein; based or sweet whey or acid whey, or their combination. Preferably, the whey protein is a source of whey protein, containing more than 80 wt.% whey protein. A suitable whey protein concentrate is LACPRODAN 9087, and suitable sources of whey protein isolates include ALACEN 895 (New Zealand Milk Products Inc), BiPRO (Le Sueur Isolates of Le Sueur, Minn.), PROVON-190 (Avonmore Ingredients Inc of Monroe Wis.) and LACPRODAN 9212 (Royal Proteins, Inc. of Rosemont III).

The protein source may, if necessary, to include some number of other suitable types of protein. For example, the protein source may additionally contain minor quantities of casein protein, soy protein, ricovog the protein, pea protein, protein carob, oat protein, milk protein, caseino-glycomacropeptide or a mixture of these proteins. In addition, if necessary, the protein source may additionally contain minor amounts of free amino acids. Other suitable types of protein are preferably less than about 50 wt.% source of protein; more preferably less than about 30 wt.%.

Depending on the state in which the patient, a source of protein, preferably selected so that the final nutritional composition is easily digested.

High concentration of protein can be used to provide enough protein for recovery of underweight patients with elevated protein loss. Increased protein needs were identified groups of patients, such as bedsores ulcer, severe wounds, trauma, Crohn's disease with disease with protein loss, chronic diarrhoea and HIV/AIDS malabsorption and diarrhea. An essential metabolic conditions these conditions is the increased loss of nitrogen, increased need for protein, or both.

The composition of the present invention may be designed as a diet-based peptides. When choosing a protein source the present invention maximizes tolerance and absorption with p the power of hydrolyzed protein. In the preferred embodiment the source of protein is enzymatically hydrolyzed whey protein. This type of protein source reduces the incidence of gastric reflux, because gastric emptying is faster than diets containing casein or whole serum. Also hydrolyzed whey protein is a rich source of the amino acid cysteine, which is the limiting amino acid for the formation of glutathione.

The protein source preferably provides from about 8% to about 25% of the energy of nutritional support. In accordance with one embodiment of the present invention the protein source provides at least about 8%, preferably about 15-25% of the total calories of the composition. For example, the protein source can provide from about 15% to about 18% of the energy of the composition in the embodiment, suitable for adults, or from about 8% to about 14% of the energy of the composition in the embodiment, which is suitable for pediatric use.

In a particular preferred embodiment of the present invention the protein source provides at least about 8%, preferably about 15-25%of total calories of the composition, the source of lipids provides at least about 18%, preferably about 30%-50% of the total calories of the composition and preferably has a ratio of omega-6 is omega-3 from about 2:1 to about 10:1 and a source of carbohydrates gives, at least about 15%, preferably about 20%-40% of the total calories of the composition. In one embodiment of the present invention, the nutritional composition or the medicinal agent is optionally contain micronutrients, preferably selected from the group consisting of, containing, at least, of vitamin E and vitamin C.

Even more preferred are the nutrient composition and/or drug that contains a complete profile of vitamins and inorganic substances. For example, a sufficient amount of vitamins and inorganic substances can be provided to fill from about 50% to about 500% of the recommended daily allowance of vitamins and inorganic substances on the 1000 calorie nutritional support. Nutrient composition and/or medication preferably should be rich in vitamin E. for Example, the nutrient composition and/or the medicinal product may contain from 80 to 120 Units of vitamin E per 1000 kcal. More preferably, the nutritional support contains about 30 Units of vitamin E per 250 ml serving of the composition.

Moreover, the nutrient composition and/or the medicinal product have a high content of vitamin C, which provides from about 150 to about 250 mg per 1000 kcal or, preferably, about 60 mg per serving. I believe that vitamin C accelerates vyzdorovlenii granulation in patients with complex requirements to treatment. Vitamin C will support increased requirements/loss after surgery.

Nutrient composition and/or the drug is also preferably contain 200 g of folic acid and 3 g of vitamin b 12 in metered form. An alternative embodiment of the nutritional composition and/or drugs for pediatric use have modified the profile of vitamins and inorganic materials specially adapted to the special needs of this age group.

In accordance with the present invention the composition may also include a high level of zinc. Preferably, the composition provides at least about 150% of the USRDA of zinc per 1000 kcal. In one embodiment provide from 19 to 29 mg of zinc per 1000 calories. In the preferred embodiment is provided with 24 mg of zinc per 1000 calories. Elevated levels of zinc compensates for the loss of zinc and provides a high level of zinc for tissue repair in patients with high demands for treatment.

In accordance with the present invention the composition may also include increased amounts of selenium. A selenium deficiency can develop in patients with high requirements to the treatment. In accordance with the present invention are provided, at least about 40 to 60 micrograms of selenium per 1000 calories whom is osili. In the preferred embodiment provide approximately 50 micrograms of selenium per 1000 calories.

The composition of the present invention can also include a source of beta-carotene. Beta-carotene may be added to the composition to normalize the level of beta-carotene in plasma, serum and in order to avoid deficiency of beta-carotene in patients with a prolonged period of use enteral feeding. The composition preferably includes from about 1.6 to 2.4 mg per 1000 calories. This number prevents failure and provides a possible increased demands on the treatment of the patient. Moreover, the level of beta-carotene can improve concentration in plasma to near normal optimal level of 500 micrograms per liter.

The composition of the present invention can also provide increased amounts of L-carnitine and taurine to meet the increased needs of seriously ill patients with catabolic disorders. Preferably, taurine and L-carnitine are present in amounts from about 80 to 120 mg per 1000 calories. In the preferred embodiments and taurine and L-carnitine are present in amounts of about 100 mg per 1000 calories.

Further, the composition of the present invention includes reduced amounts of magnesium. Magnesium is associated with diarrhea. In one embodiment, the magnesium presence is there in the amount of approximately 237 to 355 mg per 1000 calories. In the preferred embodiment, the magnesium is present in amount of about 300 mg per 1000 calories.

Nutritional composition of the present invention, preferably, has an energy value of about 800 kcal/l to about 2000 kcal/l; for example, the energy value of from about 1000 kcal/l to about 1500 kcal/L. Preferably, the caloric content of the composition is 1.0 kcal/ml

Nutrient composition and/or the drug can be in the form of a soluble powder, a liquid concentrate, pudding, candy bars/snack or as a ready-to-eat form, suitable for oral or enteral administration. Drinking forms are particularly preferred. Various flavor additives, sweeteners and other additives may also be present. Can be used artificial sweeteners such as Acesulfame and sweeteners based on L-aspartyl; for example acesulfam-K or aspartame, or their mixture.

The composition of the present invention, preferably, is ready for enteral use form. The composition may be used as a Supplement or for total enteral nutrition. The composition can enter the patient using a probe tube or also in the form of a drink.

The amount of nutrient composition and/or drugs, demand is e for feeding the patient, will vary depending on factors such as the patient's condition, patient weight, patient age, and other power sources. However, the required number can be easily installed practitioner medical professional. The nutritional composition can be taken multiple doses, for example, from 2 to 5 times that will be required daily dose, or can be taken as a single dose.

Professionals skilled in this field will understand that you can combine any of the features presented in the present description, without leaving the scope of the disclosed invention.

Further embodiments and advantages of the present invention will become apparent from the following examples and figures.

Figure 1 shows the level of colonization of Lactobacillus johnsonii Lal colon on a Log10scale. Shown are mean values and corresponding standard derivation for group a (placebo), group b (107SOME) and group C (109SOME places).

Example 1

Intestinal microbiota consists of an extremely large number of microbes of different cell lines, which can interact with the recipient. In General, the microbiota is a real body, is involved in many functions that contribute to the health of the recipient. It receives energy from complex carbohydrates that have escaped digestion f is rontani recipient in the small intestine; it plays an important role in preventing colonization by pathogenic bacteria; and it contributes to the preservation of the mucosal barrier and the modulation of inflammatory/immune reactivity mucosa. Interestingly, after Subtotal and total colectomy metabolic and protective activity of the microbiota decrease, and consequently, postoperative complications can be enhanced due to the temporary weakening of the functions of the microbiota. It is known that patients undergoing colorectal surgery have a high risk of postoperative infections. At this critical moment a protective role may play ability as quickly as possible to restore the microbiota of the colon with the prevalence of protective probiotic strains. The purpose of this study is to demonstrate the possibility of colonization of probiotic strains in the colon of the patient in the peri-operative period by introducing them in the form of dietary supplements before and after surgery, regardless of what particular condition is treated the patient. Usually patients are under significant stress, heavy antibiotic treatment may suffer from a weakened immune system and/or are in serious danger of colonization of pathogenic and antibiotic-resistant tank is eremi, which appear more and more often in periodically sterilized premises, such as hospitals.

Patients and methods :

30 subjects suffering from adenocarcinoma of the colon, were enrolled in a double blind study and randomly divided into three groups.

Group 1: Probiotics in the high dose (109SOME places).

Group 2: Probiotics in a low dose (107SOME places).

Group 3: placebo.

Treatment.

Treatment consisted of mixing maltodextrin with Lactobacillus johnsonii Lal and Bifidobacterium BB536 (both bacterial strains were with the same level SOME two products). Placebo was pure maltodextrin. Treatment was started 3 days before the operation was stopped the day before surgery and continued postoperatively for up to 12 days after surgery.

The main parameter.

The primary result of the study, which was evaluated during surgery, was the colonization of the lumen and mucosa.

Results.

Group codes were A (placebo), (probiotics 107) and With (probiotics 109). Colonization of Lactobacillus johnsonii Lal to DO (day of operation) contents of the colon or biopsy of the mucosa was demonstrated in 3 of 11 patients in group b and in 4 of 9 patients in group C.

Table 1
The presence of bacteria in the contents of the colon or biopsy of the mucous
NoYes
LalAnd100
B83
In54

Conclusions.

These results demonstrate that the typical probiotic Lactobacillus johnsonii Lal able to colonize the distal colon rectum in patients undergoing colectomy in connection with colorectal adenocarcinoma. Patients suffering from these conditions and subjected to surgical treatment, are under stress and suffering from major local environmental modifications in the colon. Indeed, modification of the microbiota of the colon occur as a result of sudden changes in redox status of the environment of the colon, treatment with antibiotics and intestinal lavage, which removes most of the biomass of the lumen. The possibility of maintaining a stable population of probiotic bacteria will create the basic condition is La recovery microbiota. This, in turn, will lead to a better postoperative clinical status of the patient by preventing infectious complications and recovery physiology of the colon, which depends on metabolically active microorganisms.

Example 2

Nutrient finished form, made according to the present invention, is presented below.

Nutritious ready form in this case is a food product consisting of a mixture of proteins, carbohydrates, fats, vitamins and inorganic substances in quantities designed to meet 33% of the daily nutritional needs of an adult, when used in a volume of 500 ml.

16% of energy provides protein fraction, 34% provide fats and 50% provide carbohydrates.

The source of protein is 50% whey protein and 50% casein, and the recovered powder contains 4 g of protein per 100 ml (100 kcal).

Lipid fraction consists of rapeseed oil, medium chain triglycerides (medium chain triglycerides (MCT) and corn oil. The DH systems is 25% fat. The profile of fatty acids consists of 20% saturated fatty acids (LC), 40% monounsaturated fatty acids and 40% polyunsaturated fatty acids. The ratio of fatty acid n-6/n-3 is 4:1.

The carbohydrate content is 12.6 g per 100 ml of the recovered powder and is provided with maltodextrins. The product does not contain what it lactose.

The composition comprises fibers, represented by oligosaccharides (inulin), at a concentration of 1.5 g per 100 ml

The powder contains spray dried Lactobacillus johnsonii Lal at a concentration of 108SOME on g powder.

This standard is restored, the final product consists of 22 g of powder+84 ml of water to a final volume of 100 ml

1. The use of Lactobacillus johnsonii in the production of probiotic composition for the prevention of postoperative abdominal and pelvic infections due to the accumulation of fluid in the pelvic region, due to leakage in the anastomosis or due to bacterial translocation.

2. The use according to claim 1, where the probiotic composition is a nutritional composition.

3. The use according to claim 1, where the probiotic composition of a drug.

4. The use according to claim 1, where the strain Lactobacillus johnsonii presents Laclobacillus johnsonii Lal (CNCM 1-1225).

5. The use according to claim 2 or 3, where the nutritional composition or the medicinal agent further comprises a non-viable probiotic bacteria and/or obtained from probiotic material.

6. The use according to claim 2 or 3, where the nutritional composition or the medicinal agent further comprises a substrate for fermentation of probiotics.

7. The use according to claim 2 or 3, where the nutritional composition or the medicinal agent additionally contains prebiotics.

8. P is the physical alteration of any one of claims 1 to 3, where Lactobacillus johnsonii is present in an amount of about 105-1011CFU/ml, preferably about 106-109CFU/ml, most preferably about 107-108CFU/ml

9. The use according to claim 2, where the nutrient composition further comprises a source of carbohydrates, a source of lipids and protein source.

10. The use according to claim 9, where the protein source provides at least about 8%, preferably about 15-25% of the total calories of the composition; a source of lipids provides at least about 18%, preferably about 30-50% of the total calories of the composition, and preferably the ratio of omega-6 to omega-3 is from about 2:1 to about 10:1; source of carbohydrates provides at least about 15%, preferably about 20-40% of the total calories of the composition.

11. The use according to any one of claim 2, 3 or 9, where the nutritional composition or the medicinal agent additionally contains micronutrients, preferably selected from the group consisting of at least vitamin E and vitamin C.



 

Same patents:

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and pharmacology, namely a drug preparation inducing alpha and beta interferon, and may be used for treating acute respiratory viral infections (ARVI). The agent represents 5-hydroxy-4-dimethylaminomethyl-1-cyclohexyl-2methyl-3-ethyloxycarbonylindole hydrochloride.

EFFECT: invention provides intensified antiviral action.

13 tbl

FIELD: medicine.

SUBSTANCE: offered invention refers to medicine, namely dentistry, and may be used for treating children suffering maxillofacial abscesses and phlegmons. That is ensured by opening of a suppurative focus, wound bathing and drainage. With underlying conventional antibacterial therapy, an ointment containing furacilin, lidocaine and dibunol as active agents and a styrene maleic anhydride copolymer, Lutrol F-127 and purified water in certain proportions as an ointment base is introduced in the suppurative cavity. Furacilin - 0.2, Lidocaine - 5.0, Dibunol - 5.0, Styrene maleic anhydride copolymer - 2.0, Lutrol F-127 2.0 and Purified water to 100.0.

EFFECT: use of the given invention reducing length of wound cleaning and epithelisation in children due to the use of the ointment in presented proportions.

2 ex

FIELD: chemistry.

SUBSTANCE: invention relates to biologically active peptide complexes with immunomodulating and antiviral activity. The disclosed peptide complexes have a three-dimensional structure wherein X1 is absent or contains at least 1 amino acid; R1 and R2 are peptide chains which contain amino acid residues, His or Cys, capable of reacting with transition metal ions, wherein R1 contains up to 5 amino acid residues or is absent; R2 contains up to 3 amino acid residues or is absent.

EFFECT: peptide complexes rich in histidine and, primarily alloferon peptides with Zn ions, enable to produce preparations with a directed mechanism of action and enable their design in accordance with the understanding of the structure of the medicinal target.

3 cl, 7 dwg, 2 tbl, 6 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: claimed invention relates to derivatives of antibiotics, which represent compounds of formula (I) and their pharmaceutically acceptable salts, where U, V, W, X, R1, R2, R3, R4, R5, R6, A, B, D, E, G, m and n are determined in description. Invention also relates to pharmaceutical composition, containing said compounds and their application for obtaining medication for prevention or treatment of bacterial infections.

EFFECT: obtaining useful antimicrobial agents, efficient against various pathogens of people and animals.

23 cl, 1 tbl, 186 ex

FIELD: chemistry.

SUBSTANCE: described are lupane A-seco-triterpenoids of general formula: , where R=HCO, R1=CONHCH2CH2COOC2H2 or R=HCO, R1=thiazol-2-yl, R=R1=CONHCH2CH2COOC2H5, or R=CH2OCOCH3, R1=COOCH3 or R=CH2OCOCH2CH2COOH, R1=COOCH3 or R=CH2OCOCH2C(CH3)2COOH, R1=COOCH3 or R-CH2OCOCH2C(CH3)2CH2COOH, R'=COOCH3, which exhibit antiviral activity towards herpes simplex virus I (HSV-1, strain 1 C). Compounds with R-R1=CONHCH2CH2COOC2H5 combine antiviral activity towards herpes virus with anti-HIV activity.

EFFECT: compounds have potential in producing antiviral agents and as key intermediates in producing novel biologically active compounds.

3 cl, 9 ex, 2 tbl

FIELD: medicine.

SUBSTANCE: composition for treatment and/or prevention of infection with gastrointestinal pathogens and/or disease of mammals, associated with infection by said pathogens, contains lipid, protein and hydrocarbon part, where lipid part provides from 5 to 50% of total number of calories, protein part provides from 5 to 50% of total number of calories and carbohydrate part provided from 15 to 90% of total number of calories. Protein part contains: (i) pea protein hydrolysate and (ii) at least one source of nitrogen, selected from the group, consisting of milk proteins, milk protein hydrolysate, egg protein and egg protein hydrolysate.

EFFECT: application of claimed composition in mixture composition makes it possible to increase efficiency of treatment or prevention of infection with gastrointestinal pathogens, in particular, Helicobacter pylori, or disease of mammals, associated with said pathogen infection.

1 ex, 1 tbl

FIELD: medicine.

SUBSTANCE: invention deals with application of alkyl phospholipids with lower cytotoxicity for obtaining medication for treating diseases and/or pathophysiological conditions in mammals caused by fungi.

EFFECT: medication possesses wide spectrum of action.

4 cl, 13 tbl, 9 ex

FIELD: medicine.

SUBSTANCE: pharmaceutical oral dosage form contains a mixture treated in a melt and consisting of one active ingredient which represents a solid dispersion, at least one pharmaceutically acceptable polymer and a solubilising composition containing at least one tocopheryl-containing compound and at least one propylene glycol monofatty acid ester or a mixture of propylene glycol mono- and difatty acid esters. The active ingredient (ingredients) may be presented by a HIV protease inhibitor. The invention also refers to a method for preparing said pharmaceutical form which consists in preparing a homogenous melt of said active ingredient, said pharmaceutically acceptable polymer, and said solubilising composition, and making the melt to harden to form a solid disperse product.

EFFECT: solubilising composition provides higher biological availability of the active ingredient after the oral introduction.

FIELD: medicine.

SUBSTANCE: what is produced is a recombinant protein created by gene shuffling possessing higher antiviral and antiproliferative activities as compared with existing human interferon-alpha-2b (HulFN-α2b). The prepared polypeptide is used in a composition as an antiviral, antiproliferative, anticancer or immunomodulatory agent.

EFFECT: invention enables using the prepared high-active interferon-like protein for treating a condition sensitive to interferon therapy, cancer or viral disease.

49 cl, 9 dwg, 8 tbl, 7 ex

FIELD: medicine.

SUBSTANCE: what is presented is an antibody neutralising endothelial cell infection by human cytomegalovirus (hCMV) characterised by the presence of three heavy chain CDR and three light-chain CDR. There are described: a nucleic acid for antibody expression containing coding NA and a cell based on such expressing NA. There are disclosed: a composition for preventing and treating hCMV based on the antibody and the use of the antibody or NA for preparing a drug for treating hCMV. The invention provides the antibodies the concentration of which are required for 50% neutralisation of hCMV in endothelial cells makes 0.003 mcg/ml or less that can find further application in methods of screening, as well as in diagnosing and treating the hCMV-mediated diseases.

EFFECT: higher effectiveness of the use of the antibodies.

13 cl, 5 dwg, 2 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: there are offered: application of a water-soluble indigestible saccharide for preparing a composition wherein the composition is introduced in a pregnant woman for improving the developing intestinal microflora of an expected newborn; reinforcing the immune system and/or preventing the diseases associated with the immune system of the expected newborn; or reinforcing the immune system of the foetus (versions). What is also presented is the application of the water-soluble indigestible saccharide wherein the saccharide is a galactose-containing saccharide containing at least 50% of galactose units of the total amount of monosaccharide units found in the saccharide for preparing the composition for reinforcing the immune system of the pregnant woman; improving the vaginal flora of the pregnant woman wherein the composition is introduced in the pregnant woman.

EFFECT: increased percentage of bifidus bacteria and lactic acid bacilli in the intestinal flora of pregnant women, intestinal colonisation of the newborn by lactic acid bacilli and reinforcement of the immune system.

11 cl, 2 ex

FIELD: medicine.

SUBSTANCE: invention relates to veterinary science. A method includes the administration of a medicinal agent. The medicinal agent is presented by 0.25% alcohol solution of Chlorophyllipt 3 ml in normal saline 57 ml which is introduced intravenously twice a day for 2-3 days in dose of 60 ml per a calve if observing simple dyspepsia and four times if observing toxic dyspepsia. It is combined with the oral introduction of 1% alcohol solution of Chlorophyllipt 10 ml at 900 ml in normal saline prescribed twice a day in dose 1000 ml in both forms of dyspepsia.

EFFECT: method provides higher therapeutic effectiveness, reduces length of treatment, has no side action on calve bodies, eliminates recurrences.

1 ex

FIELD: medicine.

SUBSTANCE: strain Bifidobacterium longum B-NH is recovered from a healthy infant, actively propagates in a nutrient medium with accumulation of an production biomass in a short 12-18-hour period of cultivation time of the high bifidus bacteria concentration, is able to sour milk. The Bifidobacterium longum B-NH strain exhibits acid-forming activity, pathogen and opportunistic pathogen antagonist activity. It makes it possible to use the strain Bifidobacterium longum B-NH as an ingredient of bifidus products - bacterial preparations, biologically active food additives, fermented and non-fermented foodstuff, toiletry and care preparations enabling normalised human body microbiocenosis, including gastrointestinal and urogenital tracts, skin and mucous membranes, and extends the range of products for correction of human microflora. The strain Bifidobacterium longum B-NH is deposited in Russian National Collection of Industrial Microorganisms, No. VKPM Ac-1876.

EFFECT: invention provides higher activity of bifidus products.

2 tbl, 5 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to balneology, physiotherapy. First, individual sensitivity of patient to radon procedures is estimated. For this purpose, arterial pressure and heart rate are measured on empty stomach. After that, patient takes bath with mineral water from thermal radon springs with natural water temperature about 38°C (radon water). Patient rests for 30 minutes. After that, patient's arterial pressure and heart rate are re-measured. If heart rate does not change or changes by ±10 beats/min, and systolic and/or diastolic arterial pressure changes by ±10 mm Hg, I type of response is determined in patient. If heart rate changes by ±20 beats/min, and systolic and/or diastolic arterial pressure changes by ±15 mm Hg, II type of response is determined in patient. If heart rate changes by ±30 beats/min, and systolic and/or diastolic arterial pressure changes by ±20 mm Hg, III type of response is determined. In case of I type of response bath is taken according to the scheme: first procedure - 5 minutes, second - 8 minutes, third - 10 minutes, after that all procedures last 15 minutes. In case of II type of response bath is taken according to the scheme: first procedure - 5 minutes, second - 8 minutes, third - 10 minutes, after that all procedures last 12 minutes. In case of III type of response bath is taken according to the scheme: first procedure - 3 minutes, second - 5 minutes, third - 8 minutes, after that all procedures last 10 minutes. Course includes 10-15 baths. Bath with radon water is taken two days running, which are followed by one-day break. Treatment is performed at the background of diet No 4 b. In the first part of the day, two hours after breakfast, patient drinks 200 ml of radon water in swallows at a measured pace. On one of the days with baths, going one after another, microclysters with pantohematogen are performed. Detensor-therapy is carried out. In the second part of the day, two hours after dinner, patient drinks 200 ml of radon water in swallows at a measured pace. After that, patient takes bath with radon water. Then, procedure in accordance with programme of resonance-acoustic fluctuations (PRAF) is performed. On the days without baths in the first part of the day intestinal lavage is performed and in the second part of the day - thalassotherapy of face and body.

EFFECT: method ensures increased efficiency of treatment of patients with dysbacteriosis at resort stage due to ensuring elimination of pathogenic and opportunistic microorganisms, and increase of immunologic reactivity of organism.

4 cl, 2 tbl

FIELD: medicine.

SUBSTANCE: group of inventions refers to pharmaceutical industry and medicine and is applicable for producing and using medical immunobiological preparations containing nonpathogenic microorganisms. The compositions (versions) represent a powder containing substances containing nonpathogenic microorganisms dried up in a culture medium specified in a number: Bifidobacterium bacteria and/or Lactobacillus bacteria, and/or species-specific virulent bacteriophages, and/or species-specific bacteriophages with induced virulence or their combinations with the composition containing target additives able to form a stable foam structure, is characterised by porous structure and fragility, has a relative disintegration shrinkage at least 10 %, equivalent pore diameter 10-110 mcm at particle size no more than 100 mcm and a resting angle less than 50° in the following proportions in 1.0 g of the composition: Bifidobacterium bacteria 106-1010 CFU and/or Lactobacillus bacteria 106-1010 CFU, and/or species-specific virulent bacteriophages of Appelman's lytic activity at least 10-4 with respect to test strains and bacterial isolates recovered from a human body, and/or species-specific bacteriophages of induced virulence of Appelman's lytic activity at least 10-4 with respect to test strains and bacterial isolates recovered from a human body, target additives - the rest.

EFFECT: invention provides maximally achieved isotropic filling of the set volume of drug containers that provides accurate dosage of nonpathogenic microorganisms.

7 cl, 9 ex

FIELD: medicine.

SUBSTANCE: the invention relates to creation of pharmaceutical composition in the form of suspension with antacidic action. The said pharmaceutical composition contains calcium carbonate, polysaccharide sodium salt and excipients, where calcium carbonate is presented by “Micellate of calcium carbonate and magnesium”, polysaccharide sodium salt is sodium hyalurate. The composition additionally contains dimephosphon (dimethyloxobuthylphosphonilmethylate) and water. The excipients are alcohol, Nipagin and fructose. Offered pharmaceutical composition has specific pharmacological expressed effect, it showed atacidic action on the model of experimental gastritis. The composition has no expressed toxic effect with various doses and routes of experimental animals.

The composition has no irritant effect, sensibilizing action was not expressed.

EFFECT: the composition can be used for treatment of digestive tract pathologies and is suitable for treatment of patients additionally suffering from diabetes mellitus.

2 cl, 1 tbl, 3 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceuticals and concerns a controlled release pharmaceutical composition containing an oral dosage form of pancreatine, and an enterosoluble coating which contains a) a film-forming agent; b) a plasticiser representing mixed cetyl alcohol and triethyl citrate, and c) optionally at least one adhesion-blocking agent. The invention also concerns a method for preparing said composition and applying it for producing a pharmaceutical for digestive disorders, pancreatic exocrine insufficiency, pancreatitis, mucoviscidosis, insulin-dependent and/or insulin-independent diabetes.

EFFECT: invention provides the composition having the improved release profile and storage stability.

11 cl, 4 tbl, 14 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmaceutical industry and can be applied for increase of therapeutic-preventive properties of medicinal vegetable mixture for treatment of gastrointestinal tract diseases. Gastrointestinal herbal tea contains leaves of mint, rhizomes of sweet flag, flowers of chamomile, root of licorice and fennel fruits in defined component ratio.

EFFECT: high efficiency of herbal tea in treatment of neglected forms of disease and complications, developed before beginning of intake.

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to medicine, in particular, to field of intestine disbiosis, and can be applied for prevention or within complex therapy. Method of correcting intestinal microflora includes per oral introduction of prebiotic medication, and as prebiotic medication applied is mannose monopreparation in amount 0.01-0.02% to weight of experimental animal bode, and it is introduced in food diet of experimental animals until normal microflora is restored.

EFFECT: claimed method of intestinal microflora correction makes it possible to restore intestinal microflora, excluding risk of allergic reactions development due to application of mannose monopreparation.

1 tbl, 2 ex

FIELD: medicine.

SUBSTANCE: 1 pill 0.42 g contains a plant extract 0.1 g and excipients (potato starch, gelatin and glucose (1:1:1)) in the ratio 1:3; acetone-ethanolic solution of acetylphthalyl cellulose 5 % - 12-15 layers; a 10 % hexane solution of kollidon-25 - 3-5 layers; 64 % sugar syrup - 1-2 layers.

EFFECT: use of the invention provides preparation of the new home-produced herbal drug in the form of pills exhibiting antimicrobial, probiotic and anti-inflammatory action, with evident prolonged action, usable and having 2 years of shelf life.

5 ex, 5 tbl

FIELD: medicine.

SUBSTANCE: invention relates to feeding of newborn babies delivered by Caesarian section. Claimed is change of composition which contains long-chain polyunsaturated fatty acid and, at least, one substance, selected from group, consisting of (a) nucleotide and (b) nucleotide precursor, selected from group consisting of nucleotides, purine bases, pyridine bases, ribose and deoxyribose for obtaining composition for introduction to newborn baby delivered by Caesarian section, for treatment and/or prevention of infection, diarrhea, intestine phlegmon, allergy, atopic eczema, asthma, allergic rhinitis and/or allergic conjunctivitis. Composition can also be used to improve intestinal maturation, reduction of intestinal permeability and/or for treatment of disorders associated with intestinal barrier, in newborn baby delivered by Caesarian section. Introduced to newborn baby composition is not human breast milk.

EFFECT: invention makes it possible to improve intestinal flora of newborn babies, delivered by Caesarian section.

12 cl, 5 tbl, 6 ex

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