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

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ClinicalTrials.gov Identifier: NCT01144832
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : January 28, 2016
Information provided by (Responsible Party):
Guy Boeckxstaens, KU Leuven

Brief Summary:


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


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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: ebastine Drug: placebo capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IBS Treatment With H1-receptor Antagonists
Study Start Date : October 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Placebo Comparator: placebo capsule Drug: placebo capsule
one capsule once daily

Active Comparator: ebastine Drug: ebastine
20 milligram capsule once daily

Primary Outcome Measures :
  1. Effect of treatment on visceral sensitivity measured with rectal barostat. [ Time Frame: after 12 weeks treatment ]

Secondary Outcome Measures :
  1. Effect of treatment on IBS symptoms. [ Time Frame: after 12 weeks treatment ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144832

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University hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
KU Leuven
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Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guy Boeckxstaens, Prof. Dr., KU Leuven
ClinicalTrials.gov Identifier: NCT01144832    
Other Study ID Numbers: S51638
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by Guy Boeckxstaens, KU Leuven:
visceral hypersensitivity
mast cells
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs