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Irritable bowel syndrome
Double-blinded randomised placebo controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhoea (IBS-D)
  1. Carol Angela Howell1,
  2. Anu Kemppinen2,
  3. Victoria Allgar3,
  4. Matthew Dodd4,
  5. Charles H Knowles5,
  6. John McLaughlin6,7,
  7. Preeti Pandya8,
  8. Peter Whorwell9,
  9. Elena Markaryan1,
  10. Yan Yiannakou10,11
  1. 1 Research, Enteromed Ltd, London, UK
  2. 2 Clever Cookie Ltd, Hove, UK
  3. 3 Faculty of Health, Peninsula Medical School, Plymouth, UK
  4. 4 Department of Medical Statistics, School of Hygiene and Tropical Medicin, London, UK
  5. 5 Queen Mary University Faculty of Medicine and Dentistry, Blizard Institute, London, UK
  6. 6 Division of Diabetes, Endocrinology and Gastroenterology, The University of Manchester, Manchester, UK
  7. 7 Gastroenterology, Northern Care Alliance NHS Foundation Trust, Salford, UK
  8. 8 The Village Practice, Thornton-Cleveleys, UK
  9. 9 Neurogastroenterology Unit, Wythenshawe Hospital, Manchester, UK
  10. 10 Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Darlington, UK
  11. 11 School of Health and Life Sciences, University of Teesside, Middlesbrough, UK
  1. Correspondence to Professor Yan Yiannakou, Department of gastroenterology, County Durham and Darlington NHS Foundation Trust, Darlington, Darlington, UK; yan.yiannakou{at}nhs.net

Abstract

Objective Irritable bowel syndrome with diarrhoea (IBS-D) is a common and challenging condition that significantly reduces quality of life. Enterosgel (polymethylsiloxane polyhydrate) is an intestinal adsorbent which sequesters harmful molecules and is safe and effective in acute infective diarrhoea. This randomised controlled multicentre trial aimed to investigate its safety and efficacy in patients with IBS-D.

Design After a 2-week screening phase, participants were randomised into an 8-week double-blind phase, followed by an 8-week open-label and follow-up phase. Participants recorded stool consistency, pain and global symptoms in e-diaries and questionnaires. The primary outcome was the percentage of responders on a composite abdominal pain (≥30% decrease in the weekly score) and stool consistency (50% reduction in days per week with at least one stool of BSFS type 6 or 7) score during at least 4 weeks of the treatment period.

Results 440 patients with IBS-D were randomised to the double-blind phase with 393 continuing to the open-label phase. The Primary outcome responder rate by intention-to-treat for enterosgel versus placebo was 37.4% vs 24.3% (OR 1.95, NNT 8, p=0.002). Enterosgel also improved stool consistency (48.5% vs 32.5%, p<0.0001) abdominal pain (53.3% vs 40.2%, p=0.003), stool frequency (treatment effect −0.32 (−0.62 to −0.02)) and urgency (treatment effect −0.59 (−0.85 to −0.33)). 60% of patients reported adequate relief of symptoms after open-label treatment. Adverse event frequency was similar in both groups, with no serious events attributable to enterosgel.

Conclusion Enterosgel is safe and effective in IBS-D, providing an alternative to the limited current treatment options.

Trial registration number ISRCTN17149988.

  • irritable bowel syndrome
  • diarrhoea
  • abdominal pain

Data availability statement

Data are available on reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/gutjnl-2022-327293

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • Contributors CAH and AK: study concept and design, analysis and interpretation of data, administrative and material support and study supervision. EM: study concept and design, arranging funding, administrative and material support and overall study supervision. PP, PW: principal investigator, study design, study supervision and recruitment. CHK: study design, study supervision, analysis and interpretation of data and technical support. JM: study design, study supervision, analysis and technical support. MD, VA: statistical analysis and interpretation of data. YY: chief investigator, guarantor, study concept and design, interpretation of data, study supervision, recruitment. All authors had access to the study data and reviewed and approved the final manuscript. CAH and YY contributed equally to writing this manuscript.

    • Funding The study was funded by Bioline Products s.r.o, the legal manufacturer of the medical device Enterosgel in the EU.

    • Competing interests EM is CEO of Enteromed the study Sponsor, and exclusive distributor of Enterosgel in the UK. CAH is employed by Enteromed. YY was the chief investigator and was recompensed with CI fees paid to his institution. PW, JM, PP, CHK were members of the trial steering committee and were given a small honorarium for their time. AK was subcontracted by the sponsor as the study manager. VA, MD, JG were subcontracted by the sponsor to conduct the analysis.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • 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.