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

May 19, 2022 updated by: University Hospital, Rouen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irritable Bowel Syndrome with diarrhea
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occludin level expression in left colonic biopsies
Time Frame: day 1
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
Faecal calprotectin level
Time Frame: day 1
Level is assessed on stool sample by ELISA kit in µg/g
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Claudin level expression in left colonic biopsies
Time Frame: day 1
Claudin expression is measured using western blot (for proteins), q RT-PCR (for RNA) and IF (for localization)
day 1
Zonula Occludens (ZO)-1 level expression
Time Frame: day 1
ZO-1 expression is measured using western blot (for proteins), q RT-PCR (for RNA) and IF (for localization)
day 1
Pression pain threshold by rectal barostat
Time Frame: day 1
Pression pain threshold is measured in mmHg during rectal barostat.
day 1
Quality of life by GIQLI
Time Frame: day 1
Evaluation of quality of life using the validated score : french version of the Gastrointestinal Quality of Life Index (GIQLI)
day 1
Abdominal symptoms
Time Frame: day 1
Abdominal symptoms of IBS are assessed with IBS symptom severity scale.
day 1
Anxiety and depression level
Time Frame: day 1
Anxiety and depression are assessed with the Hospital anxiety and depression scale.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Collaborators

Société Nationale Française de Gastroentérologie

Investigators

  • Principal Investigator: Chloé Melchior, MD, Rouen University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2016

Primary Completion (Actual)

May 20, 2021

Study Completion (Actual)

May 20, 2021

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/079/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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