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

Trials

Anu Kemppinen¹  Yan Yiannakou²  Victoria Allgar³  John Gregson⁴  Matthew Dodd⁴  Peter Whorwell⁵  John McLaughlin⁵  Elena Markaryan⁶  Carol Howell⁶  Charles Knowles⁷  Preeti Pandya⁸ 

[1] Clever Cookie Ltd;County Durham and Darlington NHS Foundation Trust, University Hospital of North Durham;Department of Health Sciences, University of York;Department of Medical Statistics, London School of Hygiene and Tropical Medicine;Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester;Enteromed Ltd;Queen Mary University of London;The Village Practice;

关键词: Clinical trial;    Diarrhoea;    Enterosgel;    Intestinal adsorbent;    Irritable bowel syndrome;    Medical device;   

DOI  :  10.1186/s13063-020-4069-x

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown