Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in IBS-D Patients (SIIMPA)

University Hospital, Rouen

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Procedure: Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability

Study type: Interventional

Funder types: Other

Identifiers

NCT02550704

2015/079/HP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Irritable Bowel Syndrome with diarrhea

Experimental group

Description:

Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability. Intestinal permeability is not routinely performed and is assessed in colonic biopsies (occludin, claudin and ZO-1 by western blot, qPCR and immunofluorescence)

Treatment:

Procedure: Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability