Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the Enteric Nervous System During the Syndrome of the Irritable Bowel

Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the entérique Nervous System During the Syndrome of the Irritable Bowel

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nice, France, 06002
        • Department of gastroenterology, Hopital Archet 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients needing coloscopy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
patient with chronic inflammatory intestinal disease
colic biopsies and analysis
Other Names:
  • endoscopic biopsy
Other: 3
patient having no symptoms
colic biopsies and analysis
Other Names:
  • endoscopic biopsy
Experimental: 1
patient with irritable bowel syndrome
colic biopsies and analysis
Other Names:
  • endoscopic biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Para-cellular permeability
Time Frame: at time=0
at time=0
Gap junction protein expression
Time Frame: at time=0
at time=0
Inflammation molecule expression
Time Frame: at time=0
at time=0
Digestive discomfort degree
Time Frame: at time=0
at time=0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Thierry PICHE, PhD, Department of Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2008

Primary Completion (Actual)

September 15, 2014

Study Completion (Actual)

August 24, 2016

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimated)

August 27, 2008

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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