NCT00742118

Brief Summary

Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The investigators aimed to investigate:

  1. 1.paracellular permeability in colonic biopsies of IBS patient
  2. 2.the ability of soluble factors from colonic biopsies to reproduce in vitro these alterations

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

8 years

First QC Date

August 26, 2008

Last Update Submit

September 29, 2015

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (4)

  • Para-cellular permeability

    at time=0

  • Gap junction protein expression

    at time=0

  • Inflammation molecule expression

    at time=0

  • Digestive discomfort degree

    at time=0

Study Arms (3)

2

EXPERIMENTAL

patient with chronic inflammatory intestinal disease

Procedure: Colic biopsies

3

OTHER

patient having no symptoms

Procedure: Colic biopsies

1

EXPERIMENTAL

patient with irritable bowel syndrome

Procedure: Colic biopsies

Interventions

Colic biopsiesPROCEDURE

colic biopsies and analysis

Also known as: endoscopic biopsy
123

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients needing coloscopy

You may not qualify if:

  • Disrupted coagulation results
  • Cancer even healed
  • Known food allergy.
  • Alcohol consumption \>30g/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of gastroenterology, Hopital Archet 2

Nice, 06002, France

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Endoscopic Mucosal Resection

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

  • Thierry PICHE, PhD

    Department of Gastroenterology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry PICHE, PhD

CONTACT

piche.t@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 27, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2016

Study Completion

July 1, 2016

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

FR(1)