Intestinal Permeability and Intestinal Microbiota in Irritable Bowel Syndrome

• Status: Active, not recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Patients with diarrhea-predominant irritable bowel syndrome (IBS) and functional dyspepsia (FD) were examined and received treatment in the study. Severity of complaints and quality of life patients were assessed according to questionnaires. The state of the intestinal barrier (analysis of the protein composition, intestinal mucin levels in biopsies, serum zonulin level in blood), the composition of the gut microbiota (16S rRNA gene sequencing), bacterial metabolic function (short-chain fatty acid levels in feces), and the presence of gut inflammation (levels of lymphocytes and eosinophils in biopsies) were assessed in the patients. Patients were divided into 3 treatment groups: trimebutin + placebo, rebamipide + placebo, trimebutin + rebamipide. The above parameters were compared in patients before and after treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Criteria

Inclusion Criteria:

• Signed informed consent

• A man or woman aged 18-59.

• For women of childbearing age: mandatory use of contraceptive methods.

• Confirmed diagnosis of IBS-D and functional dyspepsia by clinical, instrumental and blood chemistry findings (according to the Clinical Guidelines of the Russian Gastroenterological Association and the Russian Association of Coloproctologists (2016)

• Absence of Helicobacter Pylori infection according to the urea breath test in the past 6 months before inclusion.

• Ability to understand and willingness to comply with all protocol details.

Exclusion Criteria:

• Prematurely discontinuation of the consumption of tested drugs/placebo;

• Started taking antibiotics, other probiotics, or prebiotics during the follow-up period;

• Refusal to participate during the follow-up period, including refusal to come for re-examination 2 months after inclusion;

• Cancer or inflammatory bowel disease diagnosis during the follow-up period.