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Intestinal Permeability and Intestinal Microbiota in Irritable Bowel Syndrome

NCT05379036 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-18

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome With Diarrhea

Interventions

DRUG

prescribing anapproved drug, examination

* Blood test to assess serum zonulin levels; * Esophagogastroduodenoscopyand colonoscopy with biopsy from the small and large intestine followed by histological examination; * Stool sample collection to assess short-chain fatty acid levels and the composition of the gut microbiota. Then the patients were prescribed therapy with the approved drug trimebutin (trimedat) with placebo or trimebutine with rebamipide or rebamipide with placebo for 2 months.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Vladimir Ivashkin · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379036 on ClinicalTrials.gov