Clinical trial NCT02550704: Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in IBS-D Patients
Official title: Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in Patients Suffering From Irritable Bowel Syndrome With Diarrhoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel syndrome
Intestinal permeability
Visceral hypersensitivity
Low grade inflammation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Société Nationale Française de Gastroentérologie
First posted: 2015-09-15
Enrollment: 34
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: Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion between these abnormalities is not known. We hypothesis there is a link between them in IBS with diarrhoea.

Detailed description: Irritable bowel syndrome (IBS) is a common functional disorder which affect around 10% of the general population. Abdominal pain and discomfort are associated with transit disorders (diarrhea, constipation, alternating). IBS is defined by Rome III criteria.

For clinicians, IBS remains difficult to treat while its pathophysiology remains not completely understood. Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three abnormalities found in IBS patients. Visceral hypersensitivity is present in 60% of the patients, while intestinal permeability is increased in a subgroup of IBS with diarrhea. Low grade inflammation could be identify with faecal calprotectin dosage. The link between this three abnormalities is not clear.

The goal of our study is to describe the prevalence of these three abnormalities in IBS-Diarrhea population and to look for a correlation between low grade inflammation, visceral hypersensitivity, increased intestinal permeability and clinical phenotypes.

Eligibility criteria: Inclusion Criteria:

* IBS-Diarrhoea according to Rome III criteria,
* Faecal calprotectin ≤200 µg/g in the last two months
* 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
* Treatment such as anti-inflammatory, probiotic in the last three months
* Patient with blood dyscrasia disorder known or identified , anticoagulant or antiplatelet treatments
* Small intestinal bacterial overgrowth (identified by a glucose breath test)
* Hypersensitivity to Normacol
* Severe renal failure
* 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
* Diet based in grapes

Primary outcomes:
measure: Occludin level expression in left colonic biopsies
timeFrame: day 1
measure: Faecal calprotectin level
timeFrame: day 1
Secondary outcomes:
measure: Claudin level expression in left colonic biopsies
timeFrame: day 1
measure: Zonula Occludens (ZO)-1 level expression
timeFrame: day 1
measure: Pression pain threshold by rectal barostat
timeFrame: day 1
measure: Quality of life by GIQLI
timeFrame: day 1
measure: Abdominal symptoms
timeFrame: day 1
measure: Anxiety and depression level
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: