drugset / Trial / NCT05379036

Intestinal Permeability and Intestinal Microbiota in Irritable Bowel Syndrome

NCT05379036

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-06-23
Primary completion
2022-05-31
Completion
2022-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Rebamipide Small molecule 300 mg
Subject Trimebutine Small molecule 600 mg