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

This study is currently recruiting participants.

Verified December 2011 by Centre Hospitalier Universitaire de Nice

Sponsor:

Collaborator:

Fondation de l'Avenir

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT00742118

First received: August 26, 2008

Last updated: December 8, 2011

Last verified: December 2011

History of Changes

Purpose

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:

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

Condition	Intervention
Irritable Bowel Syndrome	Procedure: Colic biopsies

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	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

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

Para-cellular permeability [ Time Frame: at time=0 ] [ Designated as safety issue: No ]
Gap junction protein expression [ Time Frame: at time=0 ] [ Designated as safety issue: No ]
Inflammation molecule expression [ Time Frame: at time=0 ] [ Designated as safety issue: No ]
Digestive discomfort degree [ Time Frame: at time=0 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2008
Estimated Study Completion Date:	May 2012
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2 patient with chronic inflammatory intestinal disease	Procedure: Colic biopsies colic biopsies and analysis Other Name: endoscopic biopsy
3 patient having no symptoms	Procedure: Colic biopsies colic biopsies and analysis Other Name: endoscopic biopsy
Experimental: 1 patient with irritable bowel syndrome	Procedure: Colic biopsies colic biopsies and analysis Other Name: endoscopic biopsy

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients needing coloscopy

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742118

Contacts

Contact: Thierry PICHE, PhD

piche.t@chu-nice.fr

Locations

France
Department of gastroenterology, Hopital Archet 2	Recruiting
Nice, France, 06002
Contact: Thierry PICHE, PhD piche.t@chu-nice.fr
Sub-Investigator: Raffaella DAINESE

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Fondation de l'Avenir

Investigators

Principal Investigator:

Thierry PICHE, PhD

Department of Gastroenterology

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT00742118 History of Changes
Other Study ID Numbers:	05-API-08
Study First Received:	August 26, 2008
Last Updated:	December 8, 2011
Health Authority:	France: Direction Générale de la Santé France: French Data Protection Authority France: Institutional Ethical Committee France: Ministry of Health

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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