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Aim: to optimize outcomes of the treatment and prevention of gastrointestinal diseases in adults and children. Key points. The Methodological Guidelines contain sections on the terminology, classification, mechanisms of action, requirements for sale in the Russian Federation, requirements for proving the efficacy and safety of probiotics, prebiotics, synbiotics and metabiotics, as well as functional foods enriched with them. An overview of relevant data allowing to include these drugs and products in the treatment an d prevention of gastrointestinal diseases in adults and children is presented. Conclusion. The clinical efficacy of probiotics, prebiotics, synbiotics and metabiotics depends on the specificity and quantity of their components, the dosage form, the regimen and duration of treatment. Products and functional foods with proven efficacy and safety are recommended for the treatment and prevention of gastrointestinal diseases in adults and children.

Aim: to discuss current views on the clinical significance, diagnostic opportunities, and therapeutic approaches in the treatment of small intestinal bacterial overgrowth (SIBO) as an important component in the gut microbiota function assessment, to assess the awareness of physicians and the opportunities in the diagnosis and treatment of this disease in patients in the Federal districts of the Russian Federation, as well as to present the proceedings of the Expert Council held on December 16, 2023 in Moscow.Key points. SIBO is a common syndrome often associated with irritable bowel syndrome, liver cirrhosis, asthma, and congestive heart failure, being also a predictor of early death in the elderly. Today, in many regions of the Russian Federation, there are limitations for instrumental diagnosis of this disease — lack of awareness among doctors, unavailability of gas analyzers for diagnosing SIBO, lack of information about the need to diagnose SIBO in the standards of compulsory health insurance. Rifaximin is the first-line treatment due to the highest therapeutic efficacy. One of the ways to increase the efficacy of SIBO treatment is to include strain-specific probiotics in the treatment regimen. Saccharomyces boulardii CNCM I-745 is thought to be the most studied, promising probiotic. The review also presents statistical data on the issues in the diagnosis and treatment of SIBO in the regions of the Russian Federation.Conclusion. Optimization of approaches to the diagnosis and treatment of SIBO, the development of domestic gas analyzers, increasing the awareness of physicians in all regions of the Russian Federation, as well as the development and optimization of clinical recommendations appear to be necessary measures to increase the effectiveness of medical care, the duration and quality of life of the Russian population. These goals can be achieved within the framework of Federal programs under the supervision of specialized reference centers of the Ministry of Health of the Russian Federation.

Аim: the clinical practice guidelines intended for gastroenterologists, internal medicine specialists, infectious disease specialists, general practitioners (family doctors), coloproctologists, surgeons and endoscopists present modern methods of diagnosis, prevention and treatment of C. difficile-associated disease.Key points. C. difficile-associated disease is a disease that develops when the diversity of the intestinal microbiota decreases and C. difficile excessively colonizes the colon, the toxins of which damage the intestinal muco-epithelial barrier, followed by the development of inflammation in the colon wall, with diarrhea being a characteristic clinical manifestation. The clinical presentation of the disease can vary from asymptomatic carriage, mild to moderate diarrhea that resolves on its own, to profuse watery diarrhea and pseudomembranous colitis with development of life-threatening complications. The diagnosis of C. difficile-associated disease is based on an assessment of the clinical presentation, medical history, an objective examination of the patient and laboratory stool tests. The disease severity is determined by clinical symptoms and laboratory findings. Additional diagnostic methods that are used according to indications and contribute to the assessment of severity include endoscopy of the colon and abdominal cavity imaging methods. Treatment should be initiated in cases of characteristic clinical presentation of C. difficile-associated disease and positive laboratory stool testing. The choice of drug and treatment regimen depends on the severity of the episode, the presence of complications, and whether the episode is initial, recurrent, or reinfection.Conclusion. Determination of target groups of patients for the diagnosis of clostridial infection is important in preventing overdiagnosis and subsequent unnecessary treatment. Timely diagnosis and treatment of C. difficile-associated disease help avoiding the development of life-threatening complications and improve the prognosis and quality of life of patients.

Aim: to review the modern approaches to the diagnosis and treatment of C. difficile-associated disease in adults and present the resolution of the Expert Council held on March 25, 2023 in Moscow.General provisions. C. difficile is the most important nosocomial pathogen which spores are also commonly found in the environment. Microbiota impairment, primarily due to the use of antibacterial drugs, is a key stage in the development of C. difficile-associated disease. A search for an infection should be carried out only in patients with diarrhea, and it is advisable to use at least 2 laboratory methods. The drug of choice for first-line treatment is vancomycin. If drug treatment is ineffective or the patient has recurrent clostridial infection, fecal microbiota transplantation should be considered. The probiotic strain Saccharomyces boulardii CNCM I-745 has a direct inhibitory effect on C. difficile toxin A, promotes normalization of the intestinal microbiota composition, and decreases the inflammatory reaction in colonic mucosa colonized with a toxigenic strain of C. difficile.Conclusions. Addition of the probiotic strain Saccharomyces boulardii CNCM I-745 to antibacterial therapy promotes both primary and secondary prevention of C. difficile-associated disease.

Aim: to analyze current approaches to H. pylori eradication therapy in adults and present the materials of Experts Council held on December 9, 2022 in Moscow.General statements. H. pylori infection is the main etiological factor of gastritis, peptic ulcer, and gastric cancer. Eradication of H. pylori is recognized as a necessary measure to reduce the incidence of these diseases. The approaches to selecting an eradication regimen should be optimized to take into account epidemiological trends and achieve better treatment outcomes. The updated Maastricht VI Consensus Report presents the means to overcome the difficulties in selecting an approach to the treatment of H. pylori infection. However, eradication therapy remains challenging due to adverse events (primarily antibiotic-associated diarrhea), poor treatment tolerance and patient compliance. Eradication therapy can be optimized by supplementing treatment regimens with strain-specific probiotics that reduce adverse events, improve patient compliance and eradication rates, such as Saccharomyces boulardii CNCM I-745 strain with established efficacy.Conclusion. The inclusion of certain probiotics in eradication regimens improves treatment tolerance, reduces the risk of adverse events, improves patient compliance and eradication rates.

Aim: bring to the attention of practitioners indications for anti-Helicobacter therapy, methods and procedure for diagnostics and eradication therapy of Н. pylori infection.Key points. Chronic gastritis caused by Н. pylori infection, including asymptomatic persons, may be considered as an indication for eradication therapy of Н. pylori as etiological therapy and opportunistic screening for gastric cancer prevention. Indications, for obligatory anti-Helicobacter therapy include peptic ulcer, gastric MALT lymphoma, early gastric cancer (EGC) with endoscopic resection. H. pylori primary diagnostics methods include 13C-urea breath test, H. pylori stool antigen lab test, rapid urease test and serological method. The serological method cannot be used after anti-Helicobacter therapy.In Russia H. pylori strains' resistance to clarithromycin does not exceed 15 % in most regional studies. The first line therapy for Н. pylori infection eradication is the standard triple therapy including a proton pump inhibitor (PPI), clarithromycin and amoxicillin, enhanced with bismuthate tripotassium dicitrate. A classic four-component therapy based on bismuthate tripotassium dicitrate or quadrotherapy without bismuth drug products which includes PPI, amoxicillin, clarithromycin and metronidazole, may be used as alternative to the first line eradication therapy. The standard triple therapy may be prescribed for 14 days only in those regions, where it has been proven to be effective. Quadrotherapy with bismuthate tripotassium dicitrate is also used as main second line therapy in case of standard triple therapy, bismuth enhanced standard triple therapy or combined therapy failure. Another second line therapy includes PPI, levofloxacin and amoxicillin, to which a bismuth-containing drug product may be added. The third line therapy is selected individually based on previously used treatment settings.Conclusion. In each case of H. pylori infection the decision for eradication therapy should be made, which is especially relevant as eradication of H. pylori has been recognized as an effective measure for the prevention of gastric cancer.

Aim. To optimize the choice of treatment strategies by physicians and gastroenterologists to improve treatment and prevention of small intestinal bacterial overgrowth (SIBO) in adults.Key points. SIBO is a condition characterized by an increased amount and/or abnormal composition of the microbiota in the small intestine. Clinically, the syndrome is manifested by nonspecific gastroenterological complaints and the development of malabsorption syndrome. Most often, SIBO is associated with various chronic non- infectious diseases (both diseases of the gastrointestinal tract, and the cardiovascular system and the neuromuscular apparatus) and can affect the severity of their symptoms. Specific methods for diagnosing SIBO are the culture method and breath tests. The main approaches to the treatment of SIBO include the elimination of the underlying cause of its occurrence, the use of antibacterial drugs and adherence to dietary recommendations (elemental diet).Conclusion. Small intestinal bacterial overgrowth is common in patients with various diseases, but has non-specific manifestations, so proper diagnosis of this condition is required. SIBO therapy involves prescription of antibacterial agents, the most studied of which is the non-absorbable antibiotic rifaximin-α.

Aim. To review the main indications for probiotics prescription in patients with irritable bowel syndrome and to present the materials of an Expert Council, which was held on 18 March 2022 in Moscow.Key points. Gut microbiota disturbance is an integral part of irritable bowel syndrome (IBS) pathogenesis. Changes of colonic microbiota composition are associated with its functional potential modification, which leads to an increasing of the pro-inflammatory immune response, as well as to an exacerbation of the disease symptoms and quality of life decreasing in patients with IBS. The novel coronavirus infection (COVID-19) is an independent risk factor for both exacerbation and onset of IBS, which predispose to increase IBS incidence. Correction of gut microbiota composition with probiotics seems to be a promising therapeutic target for IBS treatment optimizing. The optimal probiotic should be effective, safe, strain-specific, and its dose and duration of administration should be confirmed by the results of clinical studies. Some of the probiotics with proven efficacy in IBS are Alflorex® and Enterol®.Conclusion. Prescription of certain probiotics in IBS is advisable to normalize the frequency and consistency of stools, relieve abdominal pain and bloating, as well as improve patients’ quality of life.

Aim: evaluation of the effectiveness of the nutraceutical “Standard Zdorovia: Gastro” (“SZ Gastro”) in the treatment of patients with irritable bowel syndrome (IBS).Materials and methods. 52 patients (62 % women) diagnosed with IBS and IBS in combination with functional dyspepsia (FD) were included in the study and divided into two groups. Both groups received basic therapy according to the guidelines. The experimental group received as add-on the nutraceutical “SZ Gastro” (containing a standardized amount of menthol, gingerol and D-limonene); patients in the control group — placebo. The duration of the study was 30 days. The severity of somatic symptoms was assessed with the 7×7 questionnaire. Emotional state was assessed with the Four Dimensional Distress, Depression, Anxiety, and Somatization Questionnaire (4DSQ).Results. Patients of the experimental and control groups did not differ from each other either in terms of demographics, basic treatment, or in the severity of symptoms at the beginning of the study.The effectiveness of the treatment in the patients, who received add-on “SZ Gastro” was significantly higher than in the patients of the control group: in the control group the percentage of improvement of somatic symptoms was 22.35 %, in the experimental group it amounted to 49.18 % (χ2 = 15.9; p = 0.0001). The percentage of patients with significant decrease of emotional disturbances was also higher in the experimental group: distress (χ2 = 18.7; p = 0.0000), anxiety (χ2 = 6.9; p = 0.0097) and somatization (χ2 = 14.99; p = 0.0001). No significant side effects were registered in any of the groups.Conclusions. Add-on of nutraceutical “SZ Gastro” to basic treatment is safe and significantly increases effectiveness of the therapy in the patients with IBS and IBS in combination with PD.

Aim. A clinical observation to highlight the importance of detailed examination in patients with functional gastrointestinal symptoms.Key points. A 28-yo female patient was admitted with complains of left ileal pain, abdominal distention and up to 4-day stool delay. The complaints had long been interpreted as clinical manifestations of irritable bowel syndrome. No significant abnormalities were revealed in outpatient check-up (general and biochemical blood panels, stool test, abdominal ultrasound, oesophagogastroduodenoscopy). Colonoscopy was performed on admission, with diagnosis of rectal adenocarcinoma. The patient had a prompt surgical intervention, repeated courses of polychemotherapy and is currently followed by an oncologist and coloproctologist. No relapse signs have been reported.Conclusion. Patients with the complaints satisfying the Rome Criteria Revision IV for functional gastrointestinal diseases should have a thorough examination as per recommendations of the Russian Gastroenterological Association and Russian Association of Coloproctologists.

Aim. The practical guidelines are intended for primary care physicians, general practitioners, paediatricians, gastroenterologists and general internists to advance the treatment and prevention of gastroenterological diseases in adults and children in therapies with probiotics, prebiotics, synbiotics and their enriched functional foods.Key points. Probiotics are live microorganisms that sustain health of the host when supplied in adequate amounts. Prebiotics include human-indigestible but accessible to gut microbiota substances expediting specific changes in the composition and/or activity of gastrointestinal microbiota that favour the host health. The mechanism of probiotic action comprises the quorum resistance maintenance, nutrient substrate metabolism and end metabolite recycling, macroorganism-sustaining substrate production, as well as the mediation of local and adaptive immune responses.The Russian Federation regulates market differently for biologically active food additives (BAFA), medicinal products (drugs) and functional food products (FFP). We overview the probiotic strains regulated in Russia as BAFAs, drugs and FFPs and provide recommendations on the use of these strains in treatment and prevention of gastroenterological diseases in children and adults.Conclusion. The clinical efficacy of probiotics, prebiotics, synbiotics and fortified functional foods depends on the prebiotic and strain properties and is verified in appropriate comparative clinical trials. Not all probiotics registered in Russia as BAFAs, drugs and FFPs have a strain identity, which provides no warranty of the clinical effect expected. The FFP legislation demands improved regulation mechanisms and control for therapeutic efficacy.

Aim. To provide practical recommendations on the use of probiotics for the treatment and prevention of gastroenterological diseases in adults.General provisions. Probiotics are living microorganisms that benefit the health of the host when administered in adequate amounts. The main functions of probiotics include the support for colonisation resistance, the metabolism of food substrates and utilisation of end metabolites, the production of substrates necessary for the macro-organism, as well as the regulation of local and adaptive immune responses. Probiotics can be registered in the Russian Federation as biologically active food additives (BAFA) or as pharmaceutical products (drugs) in accordance with the microbiological standards and legislative requirements of the Russian Federation. The probiotics registered in the Russian Federation as BAFA for adults include bacteria of the Lactobacillus, Bifidobacterium, Enterococcus, Pediococcus, Lactococcus, Streptococcus, Bacillus, and Escherichia genera, and fungi of the Saccharomyces genus; probiotics registered as drugs — bacteria of Lactobid, Lactobacid, Escherichia and Enterococcus genera and fungi of the Saccharomyces genus. Some probiotics registered in the Russian Federation include probiotic strains that have proved to be effective for the prevention and treatment of antibiotic-associated diarrhea, the prevention of C. difficile-associated disease, the eradication of H. pylori infection, as well as for the treatment of irritable bowel syndrome and functional constipation.Conclusions. The clinical efficacy of probiotics depends on the probiotic strains included in their composition and is confirmed by a comparative analysis of the results of appropriate clinical studies. Not all probiotics registered in the Russian Federation as BAFA or drugs contain bacterial or fungal strains; as a result, the expected clinical effect may not be achieved.

Aim of review. To summarize the modern data on pathogenesis of symptoms irritable bowel syndrome (IBS) symptoms, to present nutraceutical product «Standart zdorovya: GASTRO» as an agent for IBS remission maintenance. Summary. Recent data indicate essential changes of intestinal microbiota in IBS in comparison to healthy population. These changes may be associated to development of inflammatory processes of intestinal wall. Long-term inflammation may result in nociceptor hypersensitivity i.e. peripheral sensitization that in turn, lead to the central sensitization and indirectly - to gastrointestinal tract (GIT) motility disorders. Besides, change of intestinal microbiota may impact the development of emotional disorders (e.g.: impaired capacity of affected intestinal microbiota to produce neurotransmitters). Therefore, according to the results of available studies, intestinal microbiota changes in IBS is a key factor for the cascade of events including intestinal wall inflammation, changes of gastrointestinal motility, decreased threshold of gastrointestinal receptor sensitivity, as well as emotional disorders resulting in development of disease symptoms. Medical preparation for IBS remission induction and remission maintenance should possess probiotic/prebiotic and anti-inflammatory properties, reduce visceral sensitivity, normalize intestinal motility and modulate patients’ emotional sphere. Due to capacity of «Standart zdorovya: GASTRO» components to deliver above-listed effects it can be promising for administration in patients with IBS.

The aim of clinical case presentation. To analyze the options of autonomous intestinal neuropathy treatment in critical state patients. Key points. The clinical cases of autonomous intestinal neuropathy of various etiology are presented. Patient A., 19-year-old patient presented with constipation for up to 3 days, progressive feeling of abdominal distention and general weakness. In the past history patient underwent surgery for chronic left-side achillobursitis. In postoperative period antibacterial treatment was prescribed that included first-generation cephalosporin. At the 4thday after onset of antibiotic treatment the patient developed chronic abdominal pain that increased progressively, diarrhea up to 10 times per day and fever of 39 °C. Subsequent investigation revealed positive stool test for C. difficile toxins A and B. Urgent colonoscopy detected pseudomembranes at colonic mucosa. Histological examination of biopsy specimens from affected sites demonstrated focal cystic dilation of crypts with epithelium desquamation, severe edema of lamina propria. Pseudomembranous colitis was diagnosed and vancomycin 125 mg qid in combined to metronidazole 500 mg tid for 10 days were prescribed. At the background of treatment stool frequency gradually decreased up to 2 times per day, hematochezia stopped. However at the 7-8th days patient developed constipation, feeling of abdominal distention and progressive general weakness. The state was regarded as development of C. difficile toxin-associated autonomous intestinal neuropathy. Patient I., 54 year-old admitted to the hospital; presenting complaints included flatulence, constipation for up to three days and severe general weakness. According to the past history in 2014 patient was diagnosed to have adenocarcinoma of the right breast gland with subsequent right-sided radical mastectomy followed by radiation therapy and chemotherapy. In May 2017 patient developed boring pain in the right lumbar area, frequent small-volume urination, febrile fever and progressive general weakness. Laboratory and instrumental investigation revealed obstructive right-sided abscessing pyelohephritis with development of sepsis; antibacterial therapy included meropenem in daily dose of 3.0 g along with correction of hypoalbuminemia and detoxication therapy. At the 3rd day of treatment patient noticed improvement in the state of health: decrease in right-sided lumbar pain and general weakness, decrease in body temperature up to subfebrile level. Catheter-collected urine sample contained no admixture of pus. However in the same day patient developed constipation along with progressive abdominal distention. The most likely cause for development of ileus in this case is development of autonomous intestinal neuropathy associated to severe intoxication. Basic mechanisms for development of autonomous intestinal neuropathy are discussed: suppression of smooth muscular contractility by C. difficile toxins A and B (in the first of presented cases) and combined autoimmune neuronal damage by immune cells due to expression of proteins by neoplastic cells (in the second case). Therapeutic approaches including prescription of prokinetic drug prucalopride and multistrain probiotic containing bifido-and lactobacilli are presented (Bifidobacterium bifidum, B. longum, B. infantis, Lactobacillus rhamnosus). Prescription of prucalopride and multistrain probiotic provided resolution of neuropathy and recovery of adequate intestinal motility due to resumption neuromuscular intestinal complex activity and correction of intestinal microbiota spectrum. Conclusion. Combination of prokinetic drug (prucalopride) and multistrain probiotic medication (Bifidobacterium bifidum, B. longum, B. infantis, Lactobacillus rhamnosus) can be effective in the treatment of autonomous intestinal neuropathy in critical care.

Aim of investigation. To estimate duration of remission of irritable bowel syndrome after treatment by multistrain probiotic drug, motility regulator or antispasmodic medication. Material and methods. Original study included overall 87 patients with irritable bowel syndrome (IBS) or IBS in combination with functional dyspepsia (FD) in whom the diagnosis was confirmed according to compliance of symptoms to the Rome-III criteria and absence of organic diseases according to laboratory and instrumental investigation. In 42 patients diarrheapredominant variant of IBS was diagnosed (IBS-D), in 45 patients - constipation-predominant (IBS-C). All patients enrolled in original study underwent monotherapy by probiotic agent, motility regulator trimebutine or spasmolytic drug. The probiotic agent (Bifidobacterium bifidum, B. longum, B. infantis, Lactobacillus rhamnosus) was prescribed to 15 patients with IBS-D and 15 patients with IBS-C, motility regulator (trimebutine) - respectively to 12 and 15 patients, antispasmodic was used in 15 patients with IBS-D and 15 - with IBS-C. All patients at the end of 28thday of treatment achieved clinical remission of the disease (decrease of the total score of «7×7» Questionnaire for 50% and more). At the 30, 45 and 60 days after treatment secession in patients had telephone interview with health-related questions. Patients’ responses of those who received no maintenance therapy were statistically analyzed. Results. In 30 days secession of pharmaceutical therapy 73.3% of patients with IBS-D who received probiotic therapy during relapse maintained clinical remission, 75% of patients often motility regulator treatment and 60% of those who received antispasmodic medications. Of patients with IBS-C in 30 days after treatment termination remission was maintained in 60% of those after probiotic treatment, in 80% of the motility regulator treatment and in 60% antispasmodic therapy. In 45 days 47% of IBS-D patients treated by probiotics had sense of well-being, 58% of those who received motility regulators and 47% of patients who received antispasmodics previously. Of IBS-C patients in 1.5 months 33.3% of those, who received probiotic were symptomless, 46,3% of patients after trimebutine therapy and 33,3% of patients who achieved remission after antispasmodic therapy. In 60 days of IBS-D 20% in the group of patients remained in remission after probiotic treatment, 20% after trimebutine therapy and 33% after antispasmodic. Of IBS-C patients 20, 33 and 20% of patients respectively maintained clinical remission. No statistically significant differences between groups of patients with IBS-D and IBS-C were revealed (р>0.05). Conclusion. According to the obtained data, pharmacologically induced remission in the most of IBS cases is short-term. Remission duration depend neither on clinical variant of disease, nor on the group of drugs applied for remission induction.

BackgroundIrritable bowel syndrome (IBS) affects 9,2% of the global population and places a considerable burden on healthcare systems. Most medications for treating IBS, including spasmolytics, laxatives, and antidiarrheals, have low efficacy. Effective and safe therapeutic treatments have yet to be developed for IBS.PurposeThis study assessed the efficacy and safety of a food supplement containing standardized menthol, limonene, and gingerol in human participants with IBS or IBS/functional dyspepsia (FD).DesignA double-blind, randomized, placebo-controlled trial.MethodsWe randomly assigned 56 patients with IBS or IBS/FD to an intervention group (Group 1) or control group (Group 2) that were given supplement or placebo, respectively, in addition to the standard treatment regimen for 30 d. Three outpatient visits were conducted during the study. Symptom severity was measured at each visit using a 7×7 questionnaire. Qualitative and quantitative composition of the intestinal microbiota were assessed at visits 1 and 3 based on 16S rRNA gene sequencing.ResultsAt visit 1 (before treatment), the median total 7×7 questionnaire score was in the moderately ill range for both groups, with no difference between the groups (p = 0.1). At visit 2, the total 7×7 score decreased to mildly ill, with no difference between the groups (p = 0.4). At visit 3, the total score for group 1 indicated borderline illness and for group 2 remained indicated mild illness (p = 0.009). Even though we observed some variations in gut microbiota between the groups, we did not find any statistically significant changes.ConclusionThe food supplement with standardized menthol, limonene, and gingerol content increased the efficacy of standard therapy in IBS and FD patients. The use of the supplement did not cause any obvious side effects.RegistrationClinicalTrials.gov Identifier: NCT04484467.