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NCT05379036

Intestinal Permeability and Intestinal Microbiota in Irritable Bowel Syndrome

Status unknown Phase 4 Last updated 18 May 2022
What this trial tests

Phase 4 trial testing prescribing anapproved drug, examination in Irritable Bowel Syndrome With Diarrhea in 60 participants. Status unknown.

Timeline
23 June 2021
Primary endpoint
31 May 2022
31 May 2022

Quick facts

Lead sponsorI.M. Sechenov First Moscow State Medical University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date23 June 2021
Primary completion31 May 2022
Estimated completion31 May 2022
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

I.M. Sechenov First Moscow State Medical University

Who can join

Adults 18 to 59, any sex, with Irritable Bowel Syndrome With Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of Rebamipide on the Intestinal Barrier, Gut Microbiota Structure and Function, and Symptom Severity Associated with Irritable Bowel Syndrome and Functional Dyspepsia Overlap: A Randomized Controlled Trial.
    Kovaleva A, Poluektova E, Maslennikov R, Karchevskaya A, et al · · 2023 · cited 3× · PMID 37763004 · DOI 10.3390/jcm12186064

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