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 provide the basic points of the Expert Panel of the Russian Gastroenterological Association with discussion of measures to improve diagnostics, treatment and management of chronic gastritis patients.Key points. In the Russian Federation in 2021 more than 30 million patients diagnosed with “Gastritis and duodenitis” were recorded (K29 in accordance with International Classification of Diseases-10). H. pylori incidence rate in the Russian population has reduced and presently is about 40 %. In chronic gastritis pattern H. pylori-associated gastritis has still dominated though gastritis percent after successful H. pylori eradication, reactive gastropathy (including reflux gastritis) and autoimmune gastritis, has increased. Endoscopic and histologic examinations serve as key diagnostic techniques that provide a means for assessing the ethiology of gastritis, topography and degree of atrophic changes, gastritis staging as per OLGA/OLGIM system that properly correlates with the risk of stomach cancer and determines endoscopic examination strategy. H. pylori eradication therapy of gastritis serves as an etiotropic treatment and makes it possible to prevent progression of atrophy and stomach cancer. Conventional triple therapy combined with bismuth tripotassium dicitrate allows for achieving optimal cure rates of H. pylori eradication. Addition of rebamipide to regimens of H. pylori eradication improves their efficiency. Rebamipide arrests symptoms of dyspepsia in the case of chronic gastritis and functional dyspepsia. The administration of rebamipide for chronic gastritis makes it possible to influence the syndrome of increased epithelial permeability and inflammation, which makes it advisable to study it as a means of preventing stomach cancer and the progression of atrophy in various types of chronic gastritis.Conclusion. Members of the Expert Panel has approved the algorithm of diagnosis and treatment of H. pylori-associated gastritis, gastritis after H. pylori eradication and H. pylori-negative gastritis at the diagnostic stage in the case of initial presentation and long-term follow-up when needed.

Aim: to investigate the clinical efficacy of two methods of oral dosing of prednisolone (in mg and mg/kg) for the induction of remission for patients with ulcerative colitis (UC) and Crohn's disease (CD) using the technology of constructing and evaluating the effectiveness function (dose-effect relationship).Material and methods. In this study were included 86 patients aged from 18 to 65 years with moderate or severe active inflammatory bowel disease (61 — UC, 25 — CD). All patients were treated with prednisolone at an initial daily dose from 30 to 60 mg with a subsequent tapering of dose. The clinical response to treatment was evaluated at the time of complete withdrawal of prednisolone using the generally accepted criteria. Two efficiency functions were constructed, compared and analyzed: the first — at the initial dosage of prednisolone in mg and the second calculating the dose in mg/kg of patient weight. The patients' body weight ranged from 41 to 98 kg. The “dose-effect” relationship for prednisolone was constructed with statistical transformation of the baseline clinical data and a quantitative expression of the actual doses and alternative responses into a graph of the effectiveness function. The mean value at each point was estimated based on the regression kernel scoring method.Results. Two graphs of the “dose-effect” of prednisolone in mg and mg/kg of patient weight were constructed. The optimal clinically effective dose (OCED) when calculated in mg/kg of weight was 0.70 ± 0.01 (0.68 + 0.72) mg/kg with the corresponding effect 79.25 ± 6.26 (66.62 91.88) %. When two graphs in mg and mg / kg of weight were superimposed, it is shown that when an initial dose of 40 mg is prescribed without taking into account the patient's weight, the effect of therapy will be 25 % lower. Prescribing a dose of 60 mg per day without weight will be optimal for patients with a body weight of 85-90 kg. With a lower body weight, the clinical effect will not decrease, but the likelihood of recognized side effects of prednisolone should be expected in proportion to the decrease in body weight.Conclusion. The clinical efficacy of two methods of prednisolone dosing (mg and mg/kg) for patients with IBD during the first induction course was compared.Using a new technology for constructing and evaluating the effectiveness function (dose-effect relationship) allowed us to prove a reliable relationship between the body weight of patients with the clinical effect of prednisolone in patients with UC and CD. Based on the analysis of the dose-effect relationship, the optimal clinically effective dose of prednisolone for patients with UC and CD during the first induction course was established, equal to 0.70 mg/kg, which can be recommended for use in clinical practice for calculating individual doses.

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 establish the consensus on controversial issues of the surgery for Сrohn’s disease by Delphi method. METHODS: a cross-sectional study was conducted by the Delphi method. 62 experts voted intramural and anonymous (31.03.23). 5 statements from the current edition of clinical guidelines were selected for correction by working group and further voting [2]. Based on the practical experience of the working group and literature data, 3 new statements were created also. Statements that do not reach the required level of agreement (80% or more) will be subjected to Round 2 of the Delphi method. RESULTS: all experts took part in the anonymous voting. The panel of experts is represented by 8 different areas of practical medicine and the median of the professional experience of the respondents was 30 (12–49) years. Of the 8 statements submitted for voting, consensus (80% or more) was reached on 6 out of 8. 2 statements have been revised by working group for the distance 2nd round of the Delphi study. Consensus (more than 80%) was reached on both. CONCLUSION: a cross-sectional study by the Delphi method provided the opinions of a panel of experts on controversial issues in the surgical treatment of Crohn’s disease. Statements that reach consensus will be included by the working group in a new edition of clinical guidelines of Crohn’s disease.

The National Registry of Patients with Inflammatory Bowel Disease (IBD) in the Russian Federation was established to study the epidemiological and clinical characteristics of patients and evaluate the actual clinical practice of medical and surgical treatment. AIM : to analyze the data of patients with IBD in the Russian Federation including clinical and demographic characteristics, medical status of patients, the frequency of use of various classes of drugs and response to treatment, the survival rates of advanced therapy drugs and the reasons for their cancellation. METHODS : from May 2017 to August 2021, depersonalized data of 3827 adult patients with IBD (ulcerative colitis (UC) – 2358 pts, Crohn's disease (CD) - 1469 pts) from 80 regions of the Russian Federation were included in the registry, both with previously and newly diagnosed UCor CD, who are in inpatient or outpatient care. RESULTS : in our population, the ratio of UC: CD was 1.6:1. The distribution of patients by sex was the same. The average age of patients in the registry was 40.6±13.1 (13-83 years) for UC and 38.5±14.3 (15-75 years) for CD, the half of patients were in the age range of 21-40 years for both diseases. The average age of disease onset did not differ for UC and CD and was 35.3 year (12-75 years) and 31.2 year (14-72 years) respectively. The duration between the onset of symptoms and the establishment of a diagnosis was 13.2 months in UC, and statistically significantly longer in CD - 34.8 months (P<0.01). The proportion of smokers in CD patients was statistically significantly higher than in UC ones (14.6% versus 9.6%, respectively, P<0.001). The incidence of disability was also significantly higher in CD than in UC patients (41.7% vs. 29.8%, P<0.01). The diagnosis of mild UC was established in 36% of cases, moderate UC occurred in 48.9% of patients, severe UC in 14.2% of patients. For the first time, the frequency of acute severe UC (1%) was estimated. The majority of patients had total UC (56.8%), 33% had left-side colitis, and 9.4% had proctitis. CD was divided by localization into ileocolitis 55.9%, terminal ileitis 23.9%, colitis 20.2%, perianal lesions were noted in 32.5% of cases. The overall complication rate in CD was 46% (681 patients), of which the most common were strictures - 48% and fistulas- 25.1%.Frequencyof extra intestinal manifestations did not differ in UC and CD patients and was 20.1% (473 patients) and 24.5% (360 patients), respectively. Of these, musculoskeletal lesions were more common (41.6% in UC, 42% in CD), lesions of the skin, eyes, mucous membranes, liver, anemia were also noted. In the treatment of IBD, steroids were used most often (79.3% and 65% in UC and CD, respectively), followed by 5-ASA - 47% in UC, 32.4% in CD. Immunosuppressant’s in CD were prescribed significantly more often (28.4%) than in UC (11%) (p<0.05). Biologics were used in 20.6% of UC patients and in 30% of CD patients. The highest 2-year survival of advanced therapy was noted for ustekinumab in CD (96%), for tofacitinib in UC (89.3%), and for vedolizumab in both UC and CD (92.5% and 88.4% respectively). The survival rates of all TNF-α inhibitors were approximately the same and varied within 58.1-72.4% in UC and 60-70% in CD. The most common reasons for discontinuation of advanced treatment were lack of efficacy/loss of response in both UC and CD. The second common reason was achieving remission. Certolizumab pegol in CD was canceled for this reason most often- 22.7% of cases. A small number of patients discontinued treatment due to adverse events: for UC - 1 patient each on adalimumab, golimumab, and tofacitinib, and 7 patients on infliximab, for CD- 5 patients on infliximab and adalimumab (9.6% and 7.5%, respectively) and 2 patients (4.6%) on certolizumab. Unfortunately, the proportion of discontinuation for non-medical reasons was significant and varied from 7% to 50% for different drugs. In some patients, the reason for discontinuation of therapy remained unknown. CONCLUSION : The difficulties of differential, often untimely diagnosis of CD and UC, the predominance of complicated and severe forms against the background of an increase in morbidity and prevalence, and at the same time the lack of adequate statistical accounting of CD and UC, make it necessary to create a unified clinical register of patients with IBD. The register of IBD patients will provide a holistic picture of the IBD situation in the country, including optimizing the use of budget funds for the treatment of patients with CD and UC, ensuring their rational planning.

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 -associ- ated disease help avoiding the development of life-threatening complications and improve the prognosis and quality of life of patients.

The aim of the study was to describe the socio-demographic characteristics, features of the course and treatment of patients with ulcerative colitis. From March 2019 to March 2021, information was collected and systematized on patients over 18 years old in the Nizhny Novgorod region suffering from IBD. The registry included and analyzed 150 unique records of patients with ulcerative colitis. According to the analysis, the number of men and women with ulcerative colitis is comparable: men - 47.3% and 52.7%. The median age of all patients was 43.0 [19.0-83.0] years. Determination of a subjective assessment of the time of onset of the first symptoms found that the median age is 37.0 [14.7-83.2] years. The median duration of the disease at the time of inclusion in the study was 26.1 [3.4; 104.5] month. During the first year, it is possible to detect pathology in 85.3% of cases: for a period of less than 3 months in 63.3% of patients, within 3 to 6 months in 16.0%, in the period from 6- up to 12 months in 6.0%. Among the examined patients, the prevalence of total colitis was established - 54.6%; in second place - the leftside colitis - 34.0%, the least common was proctitis - 11.3%. According to our data, the “average patient” will be a woman or a man of average working age who seeks medical help in a timely manner, which allows a diagnosis to be made within the first 3 months from the onset of the first symptoms; however, despite such an optimistic start, in the vast majority of cases there is a total colitis and there is no adequate control over the disease - high activity of the disease (moderate attack) and a chronic recurrent course remain, which in turn leads to the appointment of repeated courses of corticosteroids and only in a quarter of cases, therapy is changed to genetically engineered biological agents.

To determine the effective doses of prednisone for induction of remission in patients with ulcerative colitis (UC) and Crohn's disease (CD) based on the “dose-effect” relationship.

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 . 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. An analysis of digestive disease mortality dynamics in different subjects of the Russian Federation in course of the new coronavirus infection pandemic.Key points. In most subjects of the Russian Federation, the first half of 2021 enduring the COVID-19 pandemic has witnessed a higher overall mortality from digestive diseases and from peptic ulcer, liver and pancreatic illnesses compared to the same period in 2020. This situation may have roots in both the adverse impact of coronavirus infection on pre-existing digestive diseases and shortages in providing specialty medical aid to gastroenterological patients during the pandemic. Improved outpatient care and remote counselling, as well as successful educational measures, may reduce gastroenterological disease-associated mortality.Conclusion. Most regions of Russia have registered a growing mortality from digestive diseases at the new coronavirus infection pandemic due to the SARS-CoV-2 adverse impact on illness progression, as well as imposed difficulties in providing specialty medical aid.

Aim. Current clinical recommendations accentuate current methods for the diagnosis and treatment of irritable bowel syndrome (IBS).Key points. IBS is a functional bowel disorder manifested with recurrent, at least weekly, abdominal pain with the following attributes (any two leastwise): link to defecation, its frequency or stool shape. The symptoms are expected to persist for at minimum three months in a total six-month follow-up. Similar to other functional gastrointestinal (GI) disorders, IBS can be diagnosed basing on the patient symptoms compliance with Rome IV criteria, provided the absence of potentially symptom-causative organic GI diseases. Due to challenging differential diagnosis, IBS can be appropriately established per exclusionem, with pre-examination as follows: general and biochemical blood tests; tissue transglutaminase IgA/IgG antibody tests; thyroid hormones test; faecal occult blood test; hydrogen glucose/ lactulose breath test for bacterial overgrowth; stool test for enteric bacterial pathogens and Clostridium difficile A/B toxins; stool calprotectin test; abdominal ultrasound; OGDS, with biopsy as appropriate; colonoscopy with biopsy. The IBS sequence is typically wavelike, with alternating remissions and exacerbations often triggered by psychoemotional stress. Treatment of IBS patients includes dietary and lifestyle adjustments, various-class drug agents prescription and psychotherapeutic measures.Conclusion. Adherence to clinical recommendations can facilitate timely diagnosis and improve medical aid quality in patients with different clinical IBS variants.

Chronic liver disease (CLD), manifested as hepatic injury, is a major cause of global morbidity and mortality. CLD progresses to fibrosis, cirrhosis, and-ultimately-hepatocellular carcinoma (HCC) if left untreated. The different phenotypes of CLD based on their respective clinical features and causative agents include alcoholic liver disease (ALD), non-alcoholic fatty liver disease (NAFLD), metabolic-associated fatty liver disease (MAFLD), and drug-induced liver injury (DILI). The preferred treatment modality for CLD includes lifestyle modification and diet, along with limited pharmacological agents for symptomatic treatment. Moreover, oxidative stress (OS) is an important pathological mechanism underlying all CLD phenotypes; hence, the use of antioxidants to manage the disease is justified. Based on available clinical evidence, silymarin can be utilized as a hepatoprotective agent, given its potent antioxidant, antifibrotic, and anti-inflammatory properties. The role of silymarin in suppressing OS has been well established, and therefore silymarin is recommended for use in ALD and NAFLD in the guidelines approved by the Russian Medical Scientific Society of Therapists and the Gastroenterology Scientific Society of Russia. However, to discuss the positioning of the original silymarin in clinical guidelines and treatment protocols as a hepatoprotective agent for managing CLD concomitantly with other therapies, an expert panel of international and Russian medical professionals was convened on 11 November 2020. The panel reviewed approaches for the prevention and treatment of OS, existing guidelines for patient management for CLD, and available evidence on the effectiveness of silymarin in reducing OS, fibrosis, and hepatic inflammation and presented in the form of a narrative review. Key messages An expert panel of international and Russian medical professionals reviewed existing guidelines for ALD, NAFLD, MAFLD, and DILI to establish consensus recommendations that oxidative stress is the common pathophysiological mechanism underlying these conditions. The panel also discussed the positioning of original silymarin in clinical guidelines and treatment protocols as a hepatoprotective agent for managing CLD concomitantly with other therapies. The panel reviewed the effectiveness of 140 mg original silymarin three times a day in reducing oxidative stress in chronic liver diseases such as ALD, NAFLD, MAFLD, and DILI.

Анемия – наиболее частое системное осложнение и внекишечное проявление заболеваний желудочно-кишечного тракта, в большинстве случаев являющееся уникальным примером сочетания хронического дефицита железа и анемии хронического заболевания. В данном случае анемия не просто лабораторный маркер, а осложнение, требующее соответствующих диагностических и терапевтических подходов. При этом многие мировые клинические рекомендации, в т. ч. гастроэнтерологической направленности, не содержат актуальной научной информации по наиболее эффективным средствам с благоприятным профилем безопасности – внутривенным препаратам железа, которые могут использоваться и для коррекции анемии, и для восполнения дефицита железа, доказательная база по которым быстро прирастает качественными исследованиями, а также систематическими обзорами и метаанализами.