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

Irritable Bowel Syndrome Clinical Trial

— BISII  

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 ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877654
• Other study ID #: 2015/174/HP
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: May 20, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	plasmatic zonulin expression	Plasmatic zonulin expression is done using ELISA kit	day 1
Secondary	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
Secondary	Faecal calprotectin level	Level is assessed on stool sample by ELISA kit in µg/g	day 1
Secondary	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
Secondary	Abdominal symptoms	Abdominal symptoms of IBS are assessed with IBS symptom severity scale.	day 1
Secondary	Anxiety and depression levels	Anxiety and depression are assessed with the Hospital anxiety and depression scale.	day 1