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

Irritable Bowel Syndrome Clinical Trial

— SIIMPA  

Official title:

Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in Patients Suffering From Irritable Bowel Syndrome With Diarrhoea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550704
• Other study ID #: 2015/079/HP
• Status: Completed
• Phase: N/A
• Start date: May 20, 2016
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• 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 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

Related Conditions & MeSH terms

• Hypersensitivity
• Irritable Bowel Syndrome
• Syndrome

Intervention

Procedure:
• Colonoscopy with eleven 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.

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Société Nationale Française de Gastroentérologie

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), Quantitative Real Time Polymerase Chain Reaction (q RT-PCR) (RNA) and IF (for localization)	day 1
Primary	Faecal calprotectin level	Level is assessed on stool sample by ELISA kit in µg/g	day 1
Secondary	Claudin level expression in left colonic biopsies	Claudin expression is measured using western blot (for proteins), q RT-PCR (for RNA) and IF (for localization)	day 1
Secondary	Zonula Occludens (ZO)-1 level expression	ZO-1 expression is measured using western blot (for proteins), q RT-PCR (for RNA) and IF (for localization)	day 1
Secondary	Pression pain threshold by rectal barostat	Pression pain threshold is measured in mmHg during rectal barostat.	day 1
Secondary	Quality of life by 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 level	Anxiety and depression are assessed with the Hospital anxiety and depression scale.	day 1