Maastricht IBS Cohort

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by Maastricht University Medical Center
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00775060
First received: October 16, 2008
Last updated: April 19, 2011
Last verified: April 2011
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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: September 2009
Estimated Study Completion Date: September 2024
Estimated Primary Completion Date: September 2024 (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, erytromycin and serotonin reuptake inhibitors), for at least 3 days before tests.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
MaastrichtUMC Recruiting
Maastricht, Netherlands
Contact: José M Conchillo, MD PhD       j.conchillo@mumc.nl   
Principal Investigator: José M Conchillo, MD PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Ad Masclee, MD PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Prof. A.M. Masclee, MD PhD, Maastricht University Center
ClinicalTrials.gov Identifier: NCT00775060     History of Changes
Other Study ID Numbers: MEC 08-3-066
Study First Received: October 16, 2008
Last Updated: April 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on July 22, 2014