INTRODUCTION:To evaluate the prescription patterns, effectiveness, and safety of adding probiotics to Helicobacter pylori eradication therapy, in Europe. METHODS:International, prospective, noninterventional registry of the clinical practice of the European gastroenterologists. Data were collected and quality reviewed until March 2021 at AEG-REDCap. The effectiveness was evaluated by modified intention-to-treat analysis, differentiating by geographic areas. Adverse events (AEs) were categorized as mild, moderate, and severe. RESULTS:Overall, 36,699 treatments were recorded, where 8,233 (22%) were prescribed with probiotics. Probiotics use was associated with higher effectiveness in the overall analysis (odds ratio [OR] 1.631, 95% confidence interval [CI] 1.456-1.828), as well as in triple (OR 1.702, 95% CI 1.403-2.065), quadruple (OR 1.383, 95% CI 0.996-1.920), bismuth quadruple (OR 1.248, 95% CI 1.003-1.554), and sequential therapies (OR 3.690, 95% CI 2.686-5.069). Lactobacillus genus was associated with a higher therapy effectiveness in Eastern Europe when triple (OR 2.625, 95% CI 1.911-3.606) and bismuth quadruple (OR 1.587, 95% CI 1.117-2.254) first-line therapies were prescribed. In Central Europe, the use of probiotics was associated with a decrease in both the overall incidence of AEs (OR 0.656, 95% CI 0.516-0.888) and severe AEs (OR 0.312, 95% CI 0.217-0.449). Bifidobacterium genus was associated with lower overall (OR 0.725, 95% CI 0.592-0.888) and severe (OR 0.254, 95% CI 0.185-0.347) AEs, and Saccharomyces was associated with reduced overall (OR 0.54, 95% CI 0.32-0.91) and severe (OR 0.257, 95% CI 0.123-0.536) AEs under quadruple-bismuth regimen. DISCUSSION:In Europe, the use of probiotics was associated with higher effectiveness and safety of H. pylori eradication therapy. Lactobacillus improved treatment effectiveness, whereas Bifidobacterium and Saccharomyces were associated with a better safety profile.

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.

Background: The influence of indications for Helicobacter pylori investigation on prescriptions and effectiveness is unknown. The aim of the study was to assess the impact of indications for H. pylori investigation on prescriptions, effectiveness, compliance, and tolerance. Methods: International, prospective, non-interventional registry of the management of H. pylori infection by European gastroenterologists (Hp-EuReg). Treatment-n & auml;ive patients registered from 2013 to 2023 at e-CRF AEG-REDCap were analyzed. The effectiveness was assessed by modified intention-to-treat analysis. Results: Overall, 53,636 treatment-na & iuml;ve cases from 34 countries were included. Most frequent indications were: dyspepsia with normal endoscopy (49%), non-investigated dyspepsia (20%), duodenal ulcer (11%), gastric ulcer (7.7%), and gastroesophageal reflux disease (GERD) (2.6%). Therapy effectiveness varied by indication: duodenal ulcer (91%), gastric ulcer (90%), preneoplastic lesions (90%), dyspepsia with normal endoscopy (89%), GERD (88%), and non-investigated dyspepsia (87%). Bismuth-metronidazole-tetracycline and clarithromycin-amoxicillin-bismuth quadruple therapies achieved 90% effectiveness in all indications except GERD. Concomitant clarithromycin-amoxicillin-tinidazole/metronidazole reached 90% cure rates except in patients with non-investigated dyspepsia; whereas sequential clarithromycin-amoxicillin-tinidazole/metronidazole proved optimal (>= 90%) in patients with gastric ulcer only. Adverse events were higher in patients treated for dyspepsia with normal endoscopy and duodenal ulcer compared with the remaining indications (23% and 28%, p < 0.001). Therapeutic compliance was higher in patients with duodenal ulcer and preneoplastic lesions (98% and 99%, p < 0.001). Conclusion: In Europe, patients with gastric or duodenal ulcers and preneoplastic lesions showed higher H. pylori treatment effectiveness. Bismuth and non-bismuth quadruple therapies achieved optimal results in almost all indications. Trial Registration: ClinicalTrials.gov identifier: NCT02328131.

Background. One of the reasons for the decrease of Helicobacter pylori eradication effectiveness is its resistance to antibiotics. Aim. To examine the prevalence of H. pylori point mutations responsible for clarithromycin and levofloxacin resistance among the patients with upper gastrointestinal (GI) tract disorders in Kazan. Materials and methods. The study included 203 patients with symptoms of dyspepsia who underwent upper GI endoscopy at the University Hospital of Kazan Federal University (Kazan, Russia) in 2019–2021. DNA isolation from gastric antrum mucosal biopsies was performed using PureLink Genomic DNA Mini Kits (Thermo Fisher Scientific, USA). Polymerase chain reaction was performed using primers specific for the V-region of the 23S gene and the A subunit DNA gyrase encoding gyrA gene region. The sequencing of obtained DNA fragments was performed on 3730 DNA Analyzer. The sequences were searched for point mutations responsible for H. pylori resistance to clarithromycin (A2143G, A2142G and A2142C193 mutations) and levofloxacin (mutations of the gyrA gene). Results. H. pylori was detected in 47.78% of biopsy specimens using polymerase chain reaction. The proportion of H. pylori strains with mutations leading to clarithromycin resistance was 17.53%. Amino acid substitutions in the gyrA gene were found in 12.37% of samples. In case of two H. pylori strains (2.06%), dual resistance to clarithromycin and levofloxacin was found. Conclusion. So high incidence of mutations underlying the development of H. pylori resistance to clarithromycin and levofloxacin was observed among examined patients in Kazan.

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 systematize data on the prevalence of gastroesophageal reflux disease (GERD) in the adult population of Russia. Materials and methods. The search for studies was conducted in the electronic databases MEDLINE/PubMed, EMBASE, and RSCI (Russian Science Citation Index) from January 2000 to December 2022. The review included relevant publications in peer-reviewed periodicals in English or Russian, publications with data from cross-sectional epidemiological studies assessing the prevalence of GERD in the Russian population, studies on adult patients with GERD, and publications with detailed descriptive statistics that allow using the data in the meta-analysis. Results. The final analysis included 6 studies involving 34,192 subjects. The overall prevalence of GERD (prevalence of heartburn ± regurgitation once a week or more frequently) in the analyzed studies was 25.605% (95% confidence interval [CI] 17.913–34.147). The analysis used a random effect model, as there was significant heterogeneity between the results in both groups (I2=99.63%; p0.0001). The overall mean age of GERD patients in the study population was 48.14 (95% CI 32.25–4.03) years. The prevalence of GERD in the male population was 23.653% (95% CI 13.351–35.832) and 25.457% (95% CI 17.094–34.849) in females. Conclusion. This meta-analysis demonstrated that GERD is a common esophageal disease in the Russian population, affecting approximately one in four country residents.

Aim: to assess the composition of the microbiota of the mucous membrane of the body and the antrum of the stomach.Materials and methods. Sixty patients with dyspeptic symptoms were included into the study. Two biopsy samples of the gastric mucosa (from the body of the stomach and the antrum) were obtained from each patient. The presence of H. pylori infection was confirmed by PCR; RNA was isolated and then libraries were prepared for metatranscriptomic analysis of the 16S rRNA gene. Sequencing was performed on MiSeq (Illumina, USA) using MiSeq Reagent Kit v3 (600-cycle) (Illumina, USA).Results. The bacterial diversity decreases with the predominance of Helicobacter pylori species in H. pylori-positive patients. These results were confirmed by the Shannon index, the average value of which was 3.6 in the H. pylori-positive group and 5.4 in the H. pylori-negative group. In H. pylori-negative patients an increase in the representation of Streptococcus, Prevotella and Alloprevotella genera was observed. The level of H. pylori contamination of the gastric mucosa varies in the antrum and body of the stomach, in some cases reaching a 3.5-fold difference. Representation of other bacteria in the body and antrum of the stomach does not differ significantly.Conclusion. The bacterial composition of the stomach is dependent on the presence of H. pylori. H. pylori leads to the decrease of the bacterial diversity with the predominance of H. pylori in gastric microbiome.

H. pylori eradication therapy leads to significant changes in the gut microbiome, including influence on the gut microbiome’s functional potential. Probiotics are one of the most studied potential methods for reducing the microbiota-related consequences of antibiotics. However, the beneficial effects of probiotics are still under discussion. In addition, there are some concerns about the safety of probiotics, emphasizing the need for research of other therapeutic interventions. The aim of our study was to evaluate the influence of butyric acid+inulin supplements on gut microbiota changes (the gut microbiota composition, abundance of metabolic pathways, and gut resistome) caused by H. pylori eradication therapy. Materials and methods. Twenty two H. pylori-positive patients, aged 19 to 64 years, were enrolled in the study and randomized into two treatment groups, as follows: (1) ECAB-14 (n = 11), with esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and bismuthate tripotassium dicitrate 240 mg, twice daily, per os, for 14 days, and (2), ECAB-Z-14 (n = 11), with esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and bismuthate tripotassium dicitrate 240 mg, twice daily, along with butyric acid+inulin (Zacofalk), two tablets daily, each containing 250 mg of butyric acid, and 250 mg of inulin, per os, for 14 days. Fecal samples were collected from each subject prior to eradication therapy (time point I), after the end of eradication therapy (time point II), and a month after the end of eradication therapy (time point III). The total DNA from the fecal samples was isolated for whole genome sequencing using the Illumina NextSeq 500 platform. Qualitative and quantitative changes in gut microbiota were assessed, including alpha and beta diversity, functional potential and antibiotic resistance gene profiling. Results. Gut microbiota alpha diversity significantly decreased compared with the baseline immediately after eradication therapy in both treatment groups (ECAB-14 and ECAB-Z-14). This diversity reached its baseline in the ECAB-Z-14 treatment group a month after the end of eradication therapy. However, in the ECAB-14 treatment arm, a reduction in the Shannon index was observed up to a month after the end of H. pylori eradication therapy. Fewer alterations in the gut microbiota functional potential were observed in the ECAB-Z-14 treatment group. The abundance of genes responsible for the metabolic pathway associated with butyrate production decreased only in the ECAB-14 treatment group. The prevalence of antibiotic-resistant genes in the gut microbiota increased significantly in both treatment groups by the end of treatment. However, more severe alterations were noted in the ECAB-14 treatment group. Conclusions. H. pylori eradication therapy leads to taxonomic changes, a reduction in the alpha diversity index, and alterations in the functional potential of the gut microbiota and gut resistome. Taking butyric acid+inulin supplements during H. pylori eradication therapy could help maintain the gut microbiota in its initial state and facilitate its recovery after H. pylori eradication.

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.

Crohn's disease (CD) is a chronic relapsing inflammatory bowel disease of unknown etiology. Genetic predisposition and dysbiotic gut microbiota are important factors in the pathogenesis of CD. In this study, we analyzed the taxonomic composition of the gut microbiota and genotypes of 24 single nucleotide polymorphisms (SNP) associated with the risk of CD. The studied cohorts included 96 CD patients and 24 healthy volunteers from Russia. Statistically significant differences were found in the allele frequencies for 8 SNPs and taxonomic composition of the gut microbiota in CD patients compared with controls. In addition, two types of gut microbiota communities were identified in CD patients. The main distinguishing driver of bacterial families for the first community type are Bacteroidaceae and unclassified members of the Clostridiales order, and the second type is characterized by increased abundance of Streptococcaceae and Enterobacteriaceae. Differences in the allele frequencies of the rs9858542 (BSN), rs3816769 (STAT3), and rs1793004 (NELL1) were also found between groups of CD patients with different types of microbiota communities. These findings confirm the complex multifactorial nature of CD.

This study used next-generation sequencing to characterize changes in the human gut microbiome under the influence of cigarette smoking and smoking cessation. Five days after smoking cessation, the composition of the gut microbiota tends to return to an unaffected state.

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.

The Russian consensus on prevention, diagnostic and treatment of gastric cancer was prepared on the initiative of the Moscow clinical scientific center named after A. S. Loginov according to the Delphi method. Its aim was to clarify and consolidate the opinions of specialists on the most relevant issues of prevention, diagnosis and treatment of gastric cancer. An interdisciplinary approach was provided by the participation of leading gastroenterologists, oncologists and surgeons.

The effects of acrolein and crotonaldehyde on the health of Russian smokers upon switching to heated tobacco product use were analyzed in a five-day randomized clinical trial. The findings suggest that heated tobacco products significantly reduce exposure to these toxicants, with the adverse effects becoming less pronounced in just one day and comparable to complete cessation of smoking. The dynamics of nicotine intake and metabolism in the smokers who switched to heated tobacco products remained stable throughout the study and was similar to that in the group of regular cigarette smokers. Therefore, our study, which has been performed for the first time among the Russian population, shows that smokers switching to heated tobacco products are less exposed to harmful chemicals like acrolein and crotonaldehyde and thus may be protected against some of the negative health effects often associated with regular cigarettes.

Background. First-line therapy does not always provide a high level of Helicobacter pylori eradication due to the increase of H. pylori resistance to antibiotics; therefore, it remains necessary to identify the most effective rescue treatments. The purpose of this study was to evaluate the efficacy and safety of empirical H. pylori furazolidone-containing regimens. Materials and methods. Adult H. pylori infected patients empirically treated with furazolidone-containing eradication regimens were registered in an international, prospective, multicenter non-intervention European registry on H. pylori management (Hp-EuReg). Data were collected at AEG-REDCap e-CRF from 2013 to 2021 and the quality was reviewed. Modified intention-to-treat (mITT) effectiveness analyses were performed. Results. Overall 106 patients received empirical furazolidone-containing therapy in Russia. Furazolidone was prescribed in a sequential scheme along with amoxicillin, clarithromycin and a proton pump inhibitor in 68 (64%) cases, triple regimens were prescribed in 28 (26%) patients and quadruple regimens in 10 (9.4%). Treatment duration of 7 days was assigned to 2 (1.9%) patients, 10-day eradication therapy in case of 80 (75%) and 14 days in 24 (23%) patients. Furazolidone was mainly used in first- (79%) and second-line (21%) regimens. The methods used to diagnose H. pylori infection were: histology (81%), stool antigen test (64%), 13C-urea breath test (6.6%), and rapid urease test (1.9%). The mITT effectiveness of sequential therapy was 100%; 93% with the triple therapy and 75.5% with quadruple therapy. Compliance was reported in 98% of cases. Adverse events were revealed in 5.7% of patients, mostly nausea (3.8%). No serious adverse events were reported. Conclusion. Furazolidone containing eradication regimens appear to be an effective and safe empirical therapy in Russia.