No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
The effect of budesonide on the rectal sensitivity in IBS. Participants are treated with budesonide 3 dd 3 mg or placebo during eight weeks. To assess the rectal sensitivity a barostat investigation is performed before and after the treatment-period.
Secondary outcome
The effect of budesonide on inflammation in rectal biopsy specimen and the effect of budesonide on IBS-symptoms.
Background summary
Treatment: 3 mg Budesonide TID or placebo for 2 months. Patients will undergo a barostat before and after treatment.
Prior to the barostats 6 rectal biopsies will be taken via a proctoscope.
Study objective
N/A
Intervention
3 mg Budesonide TID or placebo for 2 months
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
Inclusion criteria
Fulfilling Rome II criteria of IBS, 18-65 years of age, no other organic abnormalities explaining the complaints.
Exclusion criteria
Severe comorbidity, pregnancy/lactation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL19 |
| NTR-old | NTR40 |
| Other | : N/A |
| ISRCTN | ISRCTN31751611 |