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Maastricht IBS Cohort

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ClinicalTrials.gov Identifier: NCT00775060
Recruitment Status : Recruiting
First Posted : October 17, 2008
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Irritable Bowel Syndrome

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.

Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maastricht IBS Cohort: Phenotypical and Genotypical Characterization of Patients With Irritable Bowel Syndrome.
Study Start Date : September 2009
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 Maastricht University Medical Center 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775060


Contacts
Contact: Daisy Jonkers, PhD +31 43 3785021 d.jonkers@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Daisy Jonkers, PhD       d.jonkers@maastrichtuniversity.nl   
Principal Investigator: Daisy Jonkers, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Ad Masclee, MD, PhD Maastricht University Medical Center
More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00775060     History of Changes
Other Study ID Numbers: MEC 08-3-066
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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