Abstract
BackgroundIrritable 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/designWe 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.DiscussionThis 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 registrationISRCTN17149988. Prospectively registered on 14 November 2017.
Highlights
Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life
Demonstrating that Enterosgel® is effective and safe in IBS with diarrhoea (IBS-D) could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions
The primary objective of this trial is to determine whether treatment with Enterosgel® has a positive effect on IBS symptoms in patients with IBS-D, including stool consistency and abdominal pain
Summary
We present a protocol and study design for a multicentre, randomised, double-blind, placebo-controlled trial with an open-label treatment phase. The primary objective of this trial is to determine whether treatment with Enterosgel® has a positive effect on IBS symptoms in patients with IBS-D, including stool consistency and abdominal pain. Suggested methods to reduce placebo response include: adding a run-in phase to exclude high-responders to placebo; assessment of anxiety and depression at baseline (may be important in studies of IBS); reducing the frequency of intervention and optimizing and standardizing patient–physician relationships None of these strategies have clearly shown to be effective and some may not be possible to implement in all types of studies. We will use a patient-reported primary outcome measure recommended by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for clinical trials in IBS [36, 37]. All non-substantial amendments have been submitted to the MHRA and HRA
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
