No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
The effect of the mastcell-stabilizer ketotifen on the rectal sensitivity in IBS.
Participants are treated with ketotifen twice daily 2-6 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 the mastcell-stabilizer ketotifen on inflammation in rectal biopsy specimen and the effect of ketotifen on IBS-symptoms.
Background summary
Treatment: 2, 4 or 6 mg ketotifen BID 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
Study design
N/A
Intervention
2, 4 or 6 mg ketotifen BID 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, use of sedatives, hypnotics or antihistamines, 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 | NL15 |
| NTR-old | NTR39 |
| Other | : N/A |
| ISRCTN | ISRCTN22504486 |