Maastricht IBS Cohort
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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. |
| 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) |
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 |
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.
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| Contact: José M Conchillo, MD, PhD | +31 43 3785021 | j.conchillo@mumc.nl |
| Netherlands | |
| MaastrichtUMC | Recruiting |
| Maastricht, Netherlands | |
| Contact: José M Conchillo, MD PhD j.conchillo@mumc.nl | |
| Principal Investigator: José M Conchillo, MD PhD | |
| 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 June 18, 2013