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

Sponsor

University Hospital, Rouen (Other)

Overall Status

Completed

CT.gov ID

NCT02877654

Collaborator

(none)

Enrollment

Location

Arm

51.5

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Procedure: colonoscopy with biopsies in the left colon to assess intestinal permeability	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Assessment of Intestinal Barrier in Irritable Bowel Syndrome Patients : Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins ?

Actual Study Start Date :

Feb 2, 2017

Actual Primary Completion Date :

May 20, 2021

Actual Study Completion Date :

May 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irritable Bowel Syndrome	Procedure: colonoscopy with biopsies in the left colon to assess intestinal permeability Eleven colonic biopsies are taken in the left colon during colonoscopy. Intestinal permeability is assessed by western blot, qPCR and immunofluorescence for claudin; occludin and ZO-1. One blood sample is taken to assess plasmatic zonulin (ELISA kit).

Arm

Intervention/Treatment

Experimental: Irritable Bowel Syndrome

Procedure: colonoscopy with biopsies in the left colon to assess intestinal permeability

Eleven colonic biopsies are taken in the left colon during colonoscopy. Intestinal permeability is assessed by western blot, qPCR and immunofluorescence for claudin; occludin and ZO-1. One blood sample is taken to assess plasmatic zonulin (ELISA kit).

Outcome Measures

Primary Outcome Measures

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

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)
Faecal calprotectin level [day 1]
Level is assessed on stool sample by ELISA kit in µg/g
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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen		France	76031

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator: Chloé Melchior, MD, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT02877654

Other Study ID Numbers:

2015/174/HP

First Posted:

Aug 24, 2016

Last Update Posted:

May 26, 2022

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Rouen

Plasmatic zonulin

Irritable Bowel Syndrome

Intestinal permeability

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Syndrome

Study Results

No Results Posted as of May 26, 2022