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Completed

NCT Number: NCT02550704

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. 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)

  2. Faecal calprotectin level

    Time frame: day 1

    Level is assessed on stool sample by ELISA kit in µg/g

Secondary outcomes

  1. 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)

  2. 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)

  3. Pression pain threshold by rectal barostat

    Time frame: day 1

    Pression pain threshold is measured in mmHg during rectal barostat.

  4. 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)

  5. Abdominal symptoms

    Time frame: day 1

    Abdominal symptoms of IBS are assessed with IBS symptom severity scale.

  6. Anxiety and depression level

    Time frame: day 1

    Anxiety and depression are assessed with the Hospital anxiety and depression scale.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Société Nationale Française de Gastroentérologie

Registry information

Official study title

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

Acronym: SIIMPA

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 15, 2015
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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