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

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

ebastine

placebo capsule

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring visceral hypersensitivity, mast cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo capsule

ebastine

Arm Description

Outcomes

Primary Outcome Measures

Effect of treatment on visceral sensitivity measured with rectal barostat.

Secondary Outcome Measures

Effect of treatment on IBS symptoms.

Full Information

NCT ID

NCT01144832

First Posted

May 28, 2010

Last Updated

January 27, 2016

Sponsor

KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT01144832

Brief Title

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

Official Title

IBS Treatment With H1-receptor Antagonists

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

visceral hypersensitivity, mast cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo capsule

Arm Type

Placebo Comparator

Arm Title

ebastine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ebastine

Intervention Description

20 milligram capsule once daily

Intervention Type

Drug

Intervention Name(s)

placebo capsule

Intervention Description

one capsule once daily

Primary Outcome Measure Information:

Title

Effect of treatment on visceral sensitivity measured with rectal barostat.

Time Frame

after 12 weeks treatment

Secondary Outcome Measure Information:

Title

Effect of treatment on IBS symptoms.

Time Frame

after 12 weeks treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guy Boeckxstaens, M.D.

Organizational Affiliation

Catholic University Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

University hospitals Leuven

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

26752109

Citation

Wouters MM, Balemans D, Van Wanrooy S, Dooley J, Cibert-Goton V, Alpizar YA, Valdez-Morales EE, Nasser Y, Van Veldhoven PP, Vanbrabant W, Van der Merwe S, Mols R, Ghesquiere B, Cirillo C, Kortekaas I, Carmeliet P, Peetermans WE, Vermeire S, Rutgeerts P, Augustijns P, Hellings PW, Belmans A, Vanner S, Bulmer DC, Talavera K, Vanden Berghe P, Liston A, Boeckxstaens GE. Histamine Receptor H1-Mediated Sensitization of TRPV1 Mediates Visceral Hypersensitivity and Symptoms in Patients With Irritable Bowel Syndrome. Gastroenterology. 2016 Apr;150(4):875-87.e9. doi: 10.1053/j.gastro.2015.12.034. Epub 2016 Jan 2.

Results Reference

derived

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

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