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NCT05379036
Intestinal Permeability and Intestinal Microbiota in Irritable Bowel Syndrome
Phase 4 trial testing prescribing anapproved drug, examination in Irritable Bowel Syndrome With Diarrhea in 60 participants. Status unknown.
31 May 2022
Quick facts
| Lead sponsor | I.M. Sechenov First Moscow State Medical University |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 23 June 2021 |
| Primary completion | 31 May 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- prescribing anapproved drug, examination — full drug profile →
Conditions studied
- Irritable Bowel Syndrome With Diarrhea — all drugs for Irritable Bowel Syndrome With Diarrhea →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05379036
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05379036 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by I.M. Sechenov First Moscow State Medical University
- Last refreshed: 18 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05379036.
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