Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
Recruiting · NCT02421705 · Interventional (participants receive a specific treatment) · Lead sponsor: KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
Sample collection
What this trial is about
Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- For group 1: IBS
- Irritable Bowel Syndrome (IBS) (ROME III criteria)
- No obvious organic explanation for the IBS symptoms
- Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
- Group 2: active ulcerative colitis 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
- Group 3: ulcerative colitis in remission (3a: with IBS symptoms, 3b: without IBS symptoms)
- diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)
- remission is confirmed by at least one sigmoidoscopy
- Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
- nly for group 3a:
- Rome III criteria for IBS
- Group 4: Healthy controls No abdominal (pain) complaints.
- Group 5: active Crohn's disease
- \. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
- Group 6: Crohn's disease in remission (6a: with IBS symptoms, 6b: without IBS symptoms)
- diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)
- remission is confirmed by at least one sigmoidoscopy
- Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
Exclusion criteria
- For all groups:
- co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting
- Abdominal chirurgy (except for an uncomplicated appendectomy)
Where it is running
2 locations listed.
- University Hospitals Leuven - Leuven, Vlaams-Brabant, Belgium
- University Hospitals Leuven - Leuven, Vlaams-Brabant, Belgium