search
Back to results

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

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colic biopsies
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients needing coloscopy

Exclusion Criteria:

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

Sites / Locations

  • Department of gastroenterology, Hopital Archet 2Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

2

3

1

Arm Description

patient with chronic inflammatory intestinal disease

patient having no symptoms

patient with irritable bowel syndrome

Outcomes

Primary Outcome Measures

Para-cellular permeability
Gap junction protein expression
Inflammation molecule expression
Digestive discomfort degree

Secondary Outcome Measures

Full Information

First Posted
August 26, 2008
Last Updated
September 29, 2015
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Fondation de l'Avenir
search

1. Study Identification

Unique Protocol Identification Number
NCT00742118
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Fondation de l'Avenir

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
patient with chronic inflammatory intestinal disease
Arm Title
3
Arm Type
Other
Arm Description
patient having no symptoms
Arm Title
1
Arm Type
Experimental
Arm Description
patient with irritable bowel syndrome
Intervention Type
Procedure
Intervention Name(s)
Colic biopsies
Other Intervention Name(s)
endoscopic biopsy
Intervention Description
colic biopsies and analysis
Primary Outcome Measure Information:
Title
Para-cellular permeability
Time Frame
at time=0
Title
Gap junction protein expression
Time Frame
at time=0
Title
Inflammation molecule expression
Time Frame
at time=0
Title
Digestive discomfort degree
Time Frame
at time=0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients needing coloscopy Exclusion Criteria: Disrupted coagulation results Cancer even healed Known food allergy. Alcohol consumption >30g/day
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry PICHE, PhD
Email
piche.t@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry PICHE, PhD
Organizational Affiliation
Department of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of gastroenterology, Hopital Archet 2
City
Nice
ZIP/Postal Code
06002
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry PICHE, PhD
Email
piche.t@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Raffaella DAINESE

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs