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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

October 16, 2008
April 19, 2011
September 2009
September 2024   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00775060 on ClinicalTrials.gov Archive Site
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Maastricht IBS Cohort
Maastricht IBS Cohort: Phenotypical and Genotypical Characterization of Patients With Irritable Bowel Syndrome.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Irritable Bowel Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
September 2024
September 2024   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact: José M Conchillo, MD, PhD +31 43 3785021 j.conchillo@mumc.nl
Netherlands
 
NCT00775060
MEC 08-3-066
No
Prof. A.M. Masclee, MD PhD, Maastricht University Center
Maastricht University Medical Center
Not Provided
Study Director: Ad Masclee, MD PhD Maastricht University Medical Center
Maastricht University Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP