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NCT00775060 Clinical Trial

Maastricht IBS Cohort

Irritable Bowel Syndrome Clinical Trial

Official title:
Maastricht IBS Cohort: Phenotypical and Genotypical Characterization of Patients With Irritable Bowel Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00775060
Other study ID # MEC 08-3-066
Secondary ID
Status Recruiting
Phase N/A
First received October 16, 2008
Last updated April 6, 2016
Start date September 2009
Est. completion date September 2024

Study information
Verified date April 2016
Source Maastricht University Medical Center
Contact Daisy Jonkers, PhD
Phone +31 43 3785021
Email d.jonkers@maastrichtuniversity.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Maastricht University Medical Center Maastricht

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

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