Intestinal Permeability and Intestinal Microbiota in Irritable Bowel Syndrome

NCT05379036 | Unknown Phase 4

• 1 other identifier: 116227
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Severity of complaints

  The severity of complaints is assessed using "7×7" (7 symptoms per 7 days) questionnaire and GSRS (Gastrointestinal Symptom Rating Scale)

  change from baseline points of questionnaires at 2 months

• Low-grade inflammation

  In biopsies of the small and large intestine, numbers of eosinophils and lymphocytes in the field of view were assessed by histological examination with hematoxylin-eosin staining

  change from baseline numbers of eosinophils and lymphocytes at 2 months

Secondary Outcomes (14)

• Tight junction protein level

  change from baseline tight junction proteins levels at 2 months

• Mucin-2 expression

  change from baseline level of Mucin-2 at 2 months

• Serum zonulin

  change from baseline level of serum zonulin at 2 months

• Gut microbiome

  change from baseline composition of the gut microbiota in feces at 2 months

• Short-chain fatty acids

  change from baseline short-chain fatty acid levels at 2 months

Study Arms (4)

Group A

EXPERIMENTAL

a group of patients who, after the examination, were prescribed therapy with trimebutine 600 mg per day for 2 months

Drug: prescribing anapproved drug, examination

Group B

EXPERIMENTAL

a group of patients who, after the examination, were prescribed therapy with rebamipide 300 mg per day for 2 months

Drug: prescribing anapproved drug, examination

Group C

EXPERIMENTAL

a group of patients who, after the examination, were prescribed therapy with trimebutine 600 mg per day + rebamipide 300 mg per day for 2 months

Drug: prescribing anapproved drug, examination

Control

NO INTERVENTION

healthy volunteers

Interventions

prescribing anapproved drug, examination DRUG

* 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.

Also known as: Trimedate, Rebagit

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Prematurely discontinuation of the consumption of tested drugs/placebo;
• Started taking antibiotics, other probiotics, or prebiotics during the follow-up period;
• Cancer or inflammatory bowel disease diagnosis during the follow-up period.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Elena Poluektova

Moscow, Russia

Location

Related Publications (1)

• Ivashkin V, Poluektov Y, Kogan E, Shifrin O, Sheptulin A, Kovaleva A, Kurbatova A, Krasnov G, Poluektova E. Disruption of the pro-inflammatory, anti-inflammatory cytokines and tight junction proteins expression, associated with changes of the composition of the gut microbiota in patients with irritable bowel syndrome. PLoS One. 2021 Jun 11;16(6):e0252930. doi: 10.1371/journal.pone.0252930. eCollection 2021.

  PMID: 34115808 RESULT

Related Links

• Kovaleva A.L., Poluektova E.A., Shifrin O.S. Intestinal Barrier, Permeability and Nonspecific Inflammation in Functional Gastrointestinal Disorders. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2020;30(4):52-59. (In Russ.)

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Vladimir Ivashkin

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: May 18, 2022
• Study Start: June 23, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)