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

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Procedure: colonoscopy with biopsies in the left colon to assess intestinal permeability

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occludin level expression in left colonic biopsies	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.	day 1
plasmatic zonulin expression	Plasmatic zonulin expression is done using ELISA kit	day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Chloé Melchior, MD, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Intestinal permeability; Plasmatic zonulin
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 2015/174/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No