Irritable Bowel Syndrome - Ketotifen.

The effect of a mastcell-stabilizer on rectal sensitivity.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23097

Enrollment

Registered

2005-05-31

Start date

2005-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

2, 4 or 6 mg ketotifen BID or placebo for 2 months.

Eligibility

Inclusion criteria

Inclusion criteria: Fulfilling Rome II criteria of IBS, 18-65 years of age, no other organic abnormalities explaining the complaints.

Exclusion criteria

Exclusion criteria: Severe comorbidity, use of sedatives, hypnotics or antihistamines, pregnancy/lactation.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The effect of the mastcell-stabilizer ketotifen on inflammation in rectal biopsy specimen and the effect of ketotifen on IBS-symptoms.	—

Contacts

Public ContactG.E.E. Boeckxstaens

Academic Medical Center (AMC), Department of Gastroenterology, C2-328, P.O. Box 22660

g.e.boeckxstaens@amc.uva.nl+31 (0)20 5667375

Outcome results