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Completed

NCT Number: NCT01908465

Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

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).

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Antwerpen, Edegem, Antwerpen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ebastine

Drug

Placebo

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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)

  2. Effect of treatment on inflammatory mediators/metabolites in urine

    Time frame: after 12 weeks

    By metabolic profiling in urine samples before and after treatment

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Peripheral Histamine 1 Receptor Blockade in IBS

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Jul 25, 2013
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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