Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose:

To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.

Design:

Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Katholieke Universiteit Leuven; KU Leuven
• Treatments: Ebastine; Histamine; Histamine phosphate

Criteria

Inclusion Criteria:

• Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form

• age 18-65 years

Exclusion Criteria:

• IBS subtype with constipation

• medication: antidepressants or H1-receptor antagonists

• pregnancy, breast feeding

• co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases