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

IBS Treatment With H1-receptor Antagonists

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01144832

Enrollment

Registered

2010-06-16

Start date

2009-10-31

Completion date

2012-05-31

Last updated

2016-01-28

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

Conditions

Irritable Bowel Syndrome

Keywords

visceral hypersensitivity, mast cells

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

Interventions

DRUGebastine

20 milligram capsule once daily

DRUGplacebo capsule

one capsule once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect of treatment on visceral sensitivity measured with rectal barostat.	after 12 weeks treatment

Secondary

Measure	Time frame
Effect of treatment on IBS symptoms.	after 12 weeks treatment

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026