Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists

Lead Sponsor: KU Leuven

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). End points: End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.

• Irritable Bowel Syndrome

Intervention Type: Drug

Intervention Name: ebastine

Description: 20 milligram capsule once daily

Arm Group Label: ebastine

Intervention Type: Drug

Intervention Name: placebo capsule

Description: one capsule once daily

Arm Group Label: placebo capsule

Criteria:

Inclusion Criteria: - Irritable Bowel Syndrome (ROME III criteria) - age 18-65 years Exclusion Criteria: - medication: antidepressants or H1-receptor antagonists - pregnancy, breast feeding - co-morbidity: severe kidney- and/or liver disease

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Belgium

January 2016

Type: Principal Investigator

Investigator Affiliation: KU Leuven

Investigator Full Name: Guy Boeckxstaens

Investigator Title: Prof. Dr.

• visceral hypersensitivity
• mast cells

• Irritable Bowel Syndrome
• Syndrome

Label: placebo capsule

Type: Placebo Comparator

Label: ebastine

Type: Active Comparator

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)