Clinical trial NCT02877654: Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?
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 ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Plasmatic zonulin
Irritable Bowel Syndrome
Intestinal permeability
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: occludin level expression in left colonic biopsies
timeFrame: day 1
measure: plasmatic zonulin expression
timeFrame: day 1
Secondary outcomes:
measure: Claudin and ZO-1 level expression in left colonic biopsies
timeFrame: day 1
measure: Faecal calprotectin level
timeFrame: day 1
measure: Quality of life (GIQLI)
timeFrame: day 1
measure: Abdominal symptoms
timeFrame: day 1
measure: Anxiety and depression levels
timeFrame: day 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Chloé Melchior, MD
role: PRINCIPAL_INVESTIGATOR
References: