- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00742118
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
June 15, 2026 updated by: Centre Hospitalier Universitaire de Nice
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:
- paracellular permeability in colonic biopsies of IBS patient
- the ability of soluble factors from colonic biopsies to reproduce in vitro these alterations
Study Overview
Status
Completed
Conditions
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:
|
|
Other: 3
patient having no symptoms
|
colic biopsies and analysis
Other Names:
|
|
Experimental: 1
patient with irritable bowel syndrome
|
colic biopsies and analysis
Other Names:
|
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
Terms related to this study
Additional Relevant MeSH Terms
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Colonic Diseases
- Colonic Diseases, Functional
- Irritable Bowel Syndrome
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Diagnostic Techniques, Surgical
- Endoscopy, Gastrointestinal
- Endoscopy, Digestive System
- Diagnostic Techniques, Digestive System
- Endoscopy
- Digestive System Surgical Procedures
- Endoscopic Mucosal Resection
Other Study ID Numbers
- 05-API-08
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.