Skip to main content
OpenTrials
Completed

NCT Number: NCT02877654

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy with biopsies in the left colon to assess intestinal permeability

Procedure

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).

Primary outcomes

  1. occludin level expression in left colonic biopsies

    Time frame: 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.

  2. plasmatic zonulin expression

    Time frame: day 1

    Plasmatic zonulin expression is done using ELISA kit

Secondary outcomes

  1. Claudin and ZO-1 level expression in left colonic biopsies

    Time frame: day 1

    Claudin and ZO-1 expression is measured using western blot (for proteins), q RT-PCT (for RNA) and IF (for localization)

  2. Faecal calprotectin level

    Time frame: day 1

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

  3. Quality of life (GIQLI)

    Time frame: day 1

    Evaluation of quality of life using the validated score : french version of the Gastrointestinal Quality of Life Index (GIQLI).

  4. Abdominal symptoms

    Time frame: day 1

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

  5. Anxiety and depression levels

    Time frame: day 1

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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: BISII

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 24, 2016
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.