Maastricht IBS Cohort - Full Text View

Sponsored by:	Maastricht University Medical Center
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00775060

Purpose

To set up a cohort of at least 400 IBS patients in order to identify different patient subgroups according to phenotypical and genotypical patterns and

To set up a biobank for future translational studies on the pathophysiology of IBS, in order to identify genetic factors to unravel the pathogenesis of IBS and to provide novel therapeutic targets.

Condition
Irritable Bowel Syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Maastricht IBS Cohort: Phenotypical and Genotypical Characterization of Patients With Irritable Bowel Syndrome.

Further study details as provided by Maastricht University Medical Center:

Estimated Enrollment:	400
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2023
Estimated Primary Completion Date:	November 2023 (Final data collection date for primary outcome measure)

Detailed Description:

Aim of the present study is to set up a large cohort of IBS patients in order to identify different disease characteristics as well as aetiological and pathophysiological factors in (sub)groups of patients with this heterogeneous disorder. Various phenotypical and genotypical markers will be evaluated. For this purpose, blood and faecal samples as well as symptom questionnaires will be collected and visceral perception and intestinal permeability will be measured. In order to increase the sensitivity of the barostat procedure, a pilot study will be performed by measuring patients and healthy controls under meal stimulated and fasting conditions. We aim to set up a biobank for studies on the pathophysiology of IBS, in order to identify genetic factors that may help unravel the pathogenesis of IBS and provide novel therapeutic targets. Consent will be asked to collect data from questionnaires, to store serum samples, DNA, stool and, when endoscopy is performed for clinical reasons, also biopsy specimens.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

At least 400 patients with (suspected) IBS referred to the GI-outpatient clinic of the University Hospital Maastricht will be asked to participate in the study.

Criteria

Inclusion Criteria:

IBS-patients

Exclusion Criteria:

Severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception.
Abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy or hysterectomy.
Inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, psylliumsead (metamucil), duspatal, metoclopramide, domperidon, erytromycine and serotonin reuptake inhibitors), for at least 3 days before tests.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775060

Contacts

Contact: José M Conchillo, MD, PhD

+31 43 3785021

j.conchillo@mumc.nl

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Study Director:

Ad Masclee, MD PhD

Maastricht University Medical Center

More Information

Responsible Party:	Maastricht University Center ( Prof. A.M. Masclee, MD PhD )
Study ID Numbers:	MEC 08-3-066
Study First Received:	October 16, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00775060
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on February 05, 2009