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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742118
First Posted: August 27, 2008
Last Update Posted: September 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  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: None (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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Para-cellular permeability [ Time Frame: at time=0 ]
  • Gap junction protein expression [ Time Frame: at time=0 ]
  • Inflammation molecule expression [ Time Frame: at time=0 ]
  • Digestive discomfort degree [ Time Frame: at time=0 ]

Estimated Enrollment: 200
Study Start Date: February 2008
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: February 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00742118     History of Changes
Other Study ID Numbers: 05-API-08
First Submitted: August 26, 2008
First Posted: August 27, 2008
Last Update Posted: September 30, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases