NCT02877654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

May 26, 2022

Status Verified

September 1, 2021

Enrollment Period

4.3 years

First QC Date

August 16, 2016

Last Update Submit

May 19, 2022

Conditions

Irritable Bowel Syndrome

Keywords

Plasmatic zonulinIrritable Bowel SyndromeIntestinal permeability

Outcome Measures

Primary Outcomes (2)

  • 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.

    day 1

  • plasmatic zonulin expression

    Plasmatic zonulin expression is done using ELISA kit

    day 1

Secondary Outcomes (5)

  • Claudin and ZO-1 level expression in left colonic biopsies

    day 1

  • Faecal calprotectin level

    day 1

  • Quality of life (GIQLI)

    day 1

  • Abdominal symptoms

    day 1

  • Anxiety and depression levels

    day 1

Study Arms (1)

Irritable Bowel Syndrome

EXPERIMENTAL
Procedure: colonoscopy with biopsies in the left colon to assess intestinal permeability

Interventions

colonoscopy with biopsies in the left colon to assess intestinal permeabilityPROCEDURE

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).

Irritable Bowel Syndrome

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

ColonoscopyBiopsy

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresCytodiagnosisCytological TechniquesClinical Laboratory TechniquesSpecimen HandlingInvestigative Techniques

Study Officials

  • Chloé Melchior, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 24, 2016

Study Start

February 2, 2017

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

May 26, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)