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

KU Leuven55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

ebastineDRUG

20 milligram capsule once daily

placebo capsuleDRUG

one capsule once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Outcomes

Primary Outcomes

Effect of treatment on visceral sensitivity measured with rectal barostat.

Time frame: after 12 weeks treatment

Secondary Outcomes

Effect of treatment on IBS symptoms.

Time frame: after 12 weeks treatment

Data from ClinicalTrials.gov

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