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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
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
  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:

  1. paracellular permeability in colonic biopsies of IBS patient
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014