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  • Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: a randomised, double-blind, placebo-controlled trial

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Irritable bowel syndrome
Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: a randomised, double-blind, placebo-controlled trial
  1. Lisse Decraecker1,
  2. Danny De Looze2,
  3. David P Hirsch3,
  4. Heiko De Schepper4,5,
  5. Joris Arts6,7,
  6. Philip Caenepeel7,8,
  7. Albert J Bredenoord9,
  8. Jeroen Kolkman10,
  9. Koen Bellens1,7,
  10. Kim Van Beek11,
  11. Fedrica Pia1,
  12. Willy Peetermans12,13,
  13. Tim Vanuytsel1,7,
  14. Alexandre Denadai-Souza1,
  15. Ann Belmans14,
  16. Guy Boeckxstaens1,7
  1. 1 Department of Chronic Diseases, Metabolism, and Ageing, KU Leuven, Leuven, Belgium
  2. 2 Department of Gastroenterology and Hepatology, UZ Gent, Gent, Belgium
  3. 3 Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, The Netherlands
  4. 4 Department of Translational Research in Immunology and Inflammation, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium
  5. 5 Department of Gastroenterology and Hepatology, University Hospital Antwerp, Edegem, Belgium
  6. 6 Department of Gastroenterology, AZ Sint-Lucas Brugge, Brugge, Belgium
  7. 7 Department of Gastroenterology and Hepatology, KU Leuven University Hospitals Leuven Gasthuisberg Campus, Leuven, Belgium
  8. 8 Department of Gastroenterology, Ziekenhuis Oost-Limburg - Campus Sint Jan, Genk, Belgium
  9. 9 Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
  10. 10 Department of Gastroenterology, Medisch Spectrum Twente, Enschede, The Netherlands
  11. 11 Clinical Trial Center, KU Leuven University Hospitals Leuven Gasthuisberg Campus, Leuven, Belgium
  12. 12 Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium
  13. 13 Department of Internal Medicine, KU Leuven University Hospitals Leuven Gasthuisberg Campus, Leuven, Belgium
  14. 14 Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
  1. Correspondence to Professor Guy Boeckxstaens, Department of Chronic Diseases, Metabolism, and Ageing, KU Leuven, Leuven, Belgium; guy.boeckxstaens{at}kuleuven.be

Abstract

Objective We evaluated the histamine 1 receptor antagonist ebastine as a potential treatment for patients with non-constipated irritable bowel syndrome (IBS) in a randomised, placebo-controlled phase 2 study.

Methods Non-constipated patients with IBS fulfilling the Rome III criteria were randomly assigned to 20 mg ebastine or placebo for 12 weeks. Subjects scored global relief of symptoms (GRS) and abdominal pain intensity (API). A subject was considered a weekly responder for GRS if total or obvious relief was reported and a responder for API if the weekly average pain score was reduced by at least 30% vs baseline. The primary endpoints were the proportion of subjects who were weekly responders for at least 6 out of the 12 treatment weeks for both GRS and API (‘GRS+API’, composite endpoint) and for GRS and API separately.

Results 202 participants (32±11 years, 68% female) were randomly allocated to receive ebastine (n=101) or placebo (n=101). Treatment with ebastine resulted in significantly more responders (12%, 12/92) for GRS+API compared with placebo (4%, 4/87, p=0.047) while the proportion of responders for GRS and API separately was higher for ebastine compared with placebo, although not statistically significant (placebo vs ebastine, GRS: 7% (6/87) vs 15% (14/91), p=0.072; API: 25% (20/85) vs 37% (34/92), p=0.081).

Conclusions Our study shows that ebastine is superior to placebo and should be further evaluated as novel treatment for patients with non-constipated IBS.

Trial registration number The study protocol was approved by the local ethics committee of each study site (EudraCT number: 2013-001199-39; ClinicalTrials.gov identifier: NCT01908465).

  • abdominal pain
  • irritable bowel syndrome
  • visceral hypersensitivity
  • neural-immune interactions

Data availability statement

All data relevant to the study are included in the article or uploaded as online supplemental information.

https://doi.org/10.1136/gutjnl-2023-331634

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as online supplemental information.

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    Footnotes

    • Contributors GB conceived and designed the study protocol and has overall responsibility as the guarantor. LD, DDL, DH, HDS, JA, PC, AJB, JK, KB, KVB, FP, WP and TV contributed to patient enrolment and data acquisition. KB and KVB were responsible for data monitoring during the trial. LD, KB, AB and GB provided input in the statistical analysis plan. AB provided data management input into the design of the trial and was responsible for the statistical analysis. LD, KB, AB and GB had full access to, and verified, all data in the study. LD and GB drafted the manuscript. All authors corrected and approved the final draft of the manuscript.

    • Funding KU Leuven university grant (Global Opportunities for Associations GOA 14.011, C14/18/086) FWO PhD fellowship 11B8920N.

    • Competing interests GB is an Editorial Board Member of Gut.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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