|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 October 2015 |
|
Main ID: |
NCT00742118 |
|
Date of registration:
|
26/08/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
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
|
|
Scientific 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 |
|
Date of first enrolment:
|
February 2008 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT00742118 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Thierry PICHE, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Gastroenterology |
|
|
Name:
|
Thierry PICHE, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
piche.t@chu-nice.fr |
|
Affiliation:
|
|
|
|
Name:
|
Thierry PICHE, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
piche.t@chu-nice.fr |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients needing coloscopy
Exclusion Criteria:
- Disrupted coagulation results
- Cancer even healed
- Known food allergy.
- Alcohol consumption >30g/day
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Irritable Bowel Syndrome
|
|
Intervention(s)
|
|
Procedure: Colic biopsies
|
|
Primary Outcome(s)
|
|
Gap junction protein expression
[Time Frame: at time=0]
|
|
Digestive discomfort degree
[Time Frame: at time=0]
|
|
Para-cellular permeability
[Time Frame: at time=0]
|
|
Inflammation molecule expression
[Time Frame: at time=0]
|
|
Secondary ID(s)
|
|
05-API-08
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|