Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Procedure: colonoscopy with biopsies in the left colon to assess intestinal permeability

• Registration Number: NCT02877654
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Increased intestinal permeability is one of the main pathophysiological mechanisms involved in irritable bowel syndrome. The expression of some intestinal tight junction proteins is decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased intestinal permeability. Currently, no test used in clinical practice could assess intestinal permeability.

We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.

Detailed Description

The goal of our study is to look for a correlation between plasmatic zonulin and increased colonic permeability (assessed by the expression of intestinal tight junction proteins by western blot) in IBS patients and to look for a role of intestinal low-grade inflammation and microbiota.

Population :

IBS patients with diarrhoea or IBS with constipation or mixed with worsening of symptoms

Outcomes measures :

Plasmatic zonulin (ELISA kit) Occludin expression in colonic biopsies (western blot)

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-24
• Study Start: 2017-02-02
• Primary Completion: 2021-05-20
• Study Completion: 2021-05-20
• Status Verified: 2021-09
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• IBS-Diarrhoea, IBS-constipation or alternating with recent worsening of symptoms, according to Rome III criteria
• Effective contraception since 1 month for women in childbearing age

Exclusion Criteria

• Patients with organic and/or inflammatory digestive disease
• IBS with constipation or alternating without clinical warning sign
• Treatment such as anti-inflammatory, probiotic in the last three months
• Severe renal failure
• Hypersensitivity to Normacol
• Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments
• Anal pathology (anal fissure, hemorrhoidal thrombosis)
• Pregnant or breastfeeding women
• Person with administrative or judicial decision or under legal protection measure
• Patient participating in another trial in the last two weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irritable Bowel Syndrome	colonoscopy with biopsies in the left colon to assess intestinal permeability	-

Primary Outcome Measures

Name	Time	Method
occludin level expression in left colonic biopsies	day 1	occludin expression is measured using western blot (for proteins), q RT-PCT (for RNA) and IF (for localization).; Plasmatic zonulin is measured in plasma using ELISA kit.
plasmatic zonulin expression	day 1	Plasmatic zonulin expression is done using ELISA kit

Secondary Outcome Measures

Name	Time	Method
Faecal calprotectin level	day 1	Level is assessed on stool sample by ELISA kit in µg/g
Abdominal symptoms	day 1	Abdominal symptoms of IBS are assessed with IBS symptom severity scale.
Anxiety and depression levels	day 1	Anxiety and depression are assessed with the Hospital anxiety and depression scale.
Quality of life (GIQLI)	day 1	Evaluation of quality of life using the validated score : french version of the Gastrointestinal Quality of Life Index (GIQLI).
Claudin and ZO-1 level expression in left colonic biopsies	day 1	Claudin and ZO-1 expression is measured using western blot (for proteins), q RT-PCT (for RNA) and IF (for localization)

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France