Abstract

Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults

Kemppinen A1, Howell C2, Allgar V3, Dodd M4, Gregson J4, Knowles C5, McLaughlin J6,7, Pandya P8, Whorwell P6,9, Markaryan E2, Yiannakou Y10. Trials. 2020 Jan 30;21(1):122. doi: 10.1186/s13063-020-4069-x.A

 
     

Author information

1 Clever Cookie Ltd, Hove, UK. anu@clevercookie.net.

2 Enteromed Ltd, London, UK.

3 Department of Health Sciences, University of York, York, UK.

4 Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.

5 Queen Mary University of London, London, UK.

6 Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

7 Salford Royal NHS Foundation Trust, Salford, UK.

8 The Village Practice, Thornton-Cleveleys, UK.

9 Centre for Gastrointestinal Sciences, University of Manchester, Manchester, UK.

10 County Durham and Darlington NHS Foundation Trust, University Hospital of North Durham, Durham, UK.

Abstract

BACKGROUND: Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled, multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D.

METHODS/DESIGN: We will recruit 430 participants with IBS-D from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers and gut-related measurements from magnetic resonance imaging data.

DISCUSSION: This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions.

TRIAL REGISTRATION: ISRCTN17149988. Prospectively registered on 14 November 2017.

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