NCT02550704

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

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

September 14, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

May 20, 2016

Completed
5 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

5 years

First QC Date

September 14, 2015

Last Update Submit

May 19, 2022

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel syndromeIntestinal permeabilityVisceral hypersensitivityLow grade inflammation

Outcome Measures

Primary Outcomes (2)

  • 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)

    day 1

  • Faecal calprotectin level

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

    day 1

Secondary Outcomes (6)

  • Claudin level expression in left colonic biopsies

    day 1

  • Zonula Occludens (ZO)-1 level expression

    day 1

  • Pression pain threshold by rectal barostat

    day 1

  • Quality of life by GIQLI

    day 1

  • Abdominal symptoms

    day 1

  • +1 more secondary outcomes

Study Arms (1)

Irritable Bowel Syndrome with diarrhea

EXPERIMENTAL

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

Interventions

Colonoscopy with eleven 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.

Irritable Bowel Syndrome with diarrhea

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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

Colonoscopy

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 Procedures

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

September 14, 2015

First Posted

September 15, 2015

Study Start

May 20, 2016

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

May 26, 2022

Record last verified: 2021-09

Locations

FR(1)