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Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients? (BISII)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
colonoscopy with 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 Plasmatic zonulin, Irritable Bowel Syndrome, Intestinal permeability

Eligibility Criteria

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

Inclusion Criteria:

  • IBS-Diarrhoea, IBS-constipation or alternating with recent worsening of symptoms, according to Rome III criteria
  • 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 without clinical warning sign
  • Treatment such as anti-inflammatory, probiotic in the last three months
  • Severe renal failure
  • Hypersensitivity to Normacol
  • Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments
  • 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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irritable Bowel Syndrome

Arm Description

Outcomes

Primary Outcome Measures

occludin level expression in left colonic biopsies
occludin expression is measured using western blot (for proteins), q RT-PCT (for RNA) and IF (for localization). Plasmatic zonulin is measured in plasma using ELISA kit.
plasmatic zonulin expression
Plasmatic zonulin expression is done using ELISA kit

Secondary Outcome Measures

Claudin and ZO-1 level expression in left colonic biopsies
Claudin and ZO-1 expression is measured using western blot (for proteins), q RT-PCT (for RNA) and IF (for localization)
Faecal calprotectin level
Level is assessed on stool sample by ELISA kit in µg/g
Quality of life (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 levels
Anxiety and depression are assessed with the Hospital anxiety and depression scale.

Full Information

First Posted
August 16, 2016
Last Updated
May 19, 2022
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02877654
Brief Title
Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?
Acronym
BISII
Official Title
Assessment of Intestinal Barrier in Irritable Bowel Syndrome Patients : Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins ?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Increased intestinal permeability is one of the main pathophysiological mechanisms involved in irritable bowel syndrome. The expression of some intestinal tight junction proteins is decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased intestinal permeability. Currently, no test used in clinical practice could assess intestinal permeability. We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.
Detailed Description
The goal of our study is to look for a correlation between plasmatic zonulin and increased colonic permeability (assessed by the expression of intestinal tight junction proteins by western blot) in IBS patients and to look for a role of intestinal low-grade inflammation and microbiota. Population : IBS patients with diarrhoea or IBS with constipation or mixed with worsening of symptoms Outcomes measures : Plasmatic zonulin (ELISA kit) Occludin expression in colonic biopsies (western blot)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Plasmatic zonulin, Irritable Bowel Syndrome, Intestinal permeability

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Irritable Bowel Syndrome
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
colonoscopy with 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. One blood sample is taken to assess plasmatic zonulin (ELISA kit).
Primary Outcome Measure Information:
Title
occludin level expression in left colonic biopsies
Description
occludin expression is measured using western blot (for proteins), q RT-PCT (for RNA) and IF (for localization). Plasmatic zonulin is measured in plasma using ELISA kit.
Time Frame
day 1
Title
plasmatic zonulin expression
Description
Plasmatic zonulin expression is done using ELISA kit
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Claudin and ZO-1 level expression in left colonic biopsies
Description
Claudin and ZO-1 expression is measured using western blot (for proteins), q RT-PCT (for 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
Title
Quality of life (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 levels
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, IBS-constipation or alternating with recent worsening of symptoms, according to Rome III criteria 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 without clinical warning sign Treatment such as anti-inflammatory, probiotic in the last three months Severe renal failure Hypersensitivity to Normacol Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments 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
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

Plan to Share IPD
No

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Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?

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