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

University Hospital, Rouen67 enrolled

Overview

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.

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

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

colonoscopy with biopsies in the left colon to assess intestinal permeabilityPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Rouen University Hospital

Rouen, France

Outcomes

Primary Outcomes

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.

Time frame: day 1

plasmatic zonulin expression

Plasmatic zonulin expression is done using ELISA kit

Time frame: day 1

Secondary Outcomes

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)

Time frame: day 1

Faecal calprotectin level

Level is assessed on stool sample by ELISA kit in µg/g

Time frame: 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).

Time frame: day 1

Abdominal symptoms

Abdominal symptoms of IBS are assessed with IBS symptom severity scale.

Time frame: day 1

Anxiety and depression levels

Anxiety and depression are assessed with the Hospital anxiety and depression scale.

Time frame: day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.