Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

February 7, 2023 updated by: Guy Boeckxstaens, KU Leuven

Peripheral Histamine 1 Receptor Blockade in IBS

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • ZOL (Ziekenhuis Oost-Limburg)
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
      • Zottegem, Oost-Vlaanderen, Belgium, 9620
        • AZ Sint-Elizabeth Zottegem
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8310
        • AZ Sint-Lucas Brugge
  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800
        • Rijnstate
    • Limburg
      • Enschede, Limburg, Netherlands, 7500
        • Medisch Spectrum Twente
      • Maastricht, Limburg, Netherlands, 6202
        • AZ Maastricht
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1061
        • Sint Lucas Andreas Ziekenhuis
      • Amsterdam, Noord-Holland, Netherlands, 1105
        • Academisch Medisch Centrum
      • Blaricum, Noord-Holland, Netherlands, 1213/1261
        • Tergooiziekenuizen Blaricum/Hilversum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form
  • age 18-65 years

Exclusion Criteria:

  • IBS subtype with constipation
  • medication: antidepressants or H1-receptor antagonists
  • pregnancy, breast feeding
  • co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Placebo
Drug: Placebo
ACTIVE_COMPARATOR: Ebastine
Drug: Ebastine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of treatment on global symptom relief (of IBS complaints)
Time Frame: after 12 weeks treatment
By mean of weekly GSRS (Gastrointestinal Symptom Rating Scale )questionnaires and weekly "SGA (Subject's Global Assessment) of relief" and "SGA of Abdominal Pain and Discomfort" questionnaires
after 12 weeks treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)
Time Frame: fter 12 weeks treatment
By mean of weekly questionnaires
fter 12 weeks treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of treatment on quality of life
Time Frame: after 12 weeks treatment
By mean of 'Quality of life" questionnaire (completed at the end (after 14 weeks) and the start of the study and after 8 and 12 weeks of treatment)
after 12 weeks treatment
Effect of treatment on inflammatory mediators/metabolites in urine
Time Frame: after 12 weeks
By metabolic profiling in urine samples before and after treatment
after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

November 2, 2022

Study Completion (ACTUAL)

November 2, 2022

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (ESTIMATE)

July 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S55485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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