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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel syndrome, Intestinal permeability, Visceral hypersensitivity, Low grade inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irritable Bowel Syndrome with diarrhea

Arm 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)

Outcomes

Primary Outcome Measures

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)
Faecal calprotectin level
Level is assessed on stool sample by ELISA kit in µg/g

Secondary Outcome Measures

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)
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)
Pression pain threshold by rectal barostat
Pression pain threshold is measured in mmHg during rectal barostat.
Quality of life by GIQLI
Evaluation of quality of life using the validated score : french version of the Gastrointestinal Quality of Life Index (GIQLI)
Abdominal symptoms
Abdominal symptoms of IBS are assessed with IBS symptom severity scale.
Anxiety and depression level
Anxiety and depression are assessed with the Hospital anxiety and depression scale.

Full Information

First Posted
September 14, 2015
Last Updated
May 19, 2022
Sponsor
University Hospital, Rouen
Collaborators
Société Nationale Française de Gastroentérologie
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1. Study Identification

Unique Protocol Identification Number
NCT02550704
Brief Title
Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in IBS-D Patients
Acronym
SIIMPA
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2016 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
Société Nationale Française de Gastroentérologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel syndrome, Intestinal permeability, Visceral hypersensitivity, Low grade inflammation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irritable Bowel Syndrome with diarrhea
Arm Type
Experimental
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability
Intervention Description
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 Outcome Measure Information:
Title
Occludin level expression in left colonic biopsies
Description
Occludin expression is measured using western blot (for proteins), Quantitative Real Time Polymerase Chain Reaction (q RT-PCR) (RNA) and IF (for localization)
Time Frame
day 1
Title
Faecal calprotectin level
Description
Level is assessed on stool sample by ELISA kit in µg/g
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Claudin level expression in left colonic biopsies
Description
Claudin expression is measured using western blot (for proteins), q RT-PCR (for RNA) and IF (for localization)
Time Frame
day 1
Title
Zonula Occludens (ZO)-1 level expression
Description
ZO-1 expression is measured using western blot (for proteins), q RT-PCR (for RNA) and IF (for localization)
Time Frame
day 1
Title
Pression pain threshold by rectal barostat
Description
Pression pain threshold is measured in mmHg during rectal barostat.
Time Frame
day 1
Title
Quality of life by GIQLI
Description
Evaluation of quality of life using the validated score : french version of the Gastrointestinal Quality of Life Index (GIQLI)
Time Frame
day 1
Title
Abdominal symptoms
Description
Abdominal symptoms of IBS are assessed with IBS symptom severity scale.
Time Frame
day 1
Title
Anxiety and depression level
Description
Anxiety and depression are assessed with the Hospital anxiety and depression scale.
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloé Melchior, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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

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