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
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 and design
430 participants with IBS-D will be recruited 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.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
On 30 Jan, 2020
On 13 Jan, 2020
Received 11 Jan, 2020
Invitations sent on 06 Jan, 2020
On 06 Jan, 2020
On 06 Jan, 2020
Received 06 Jan, 2020
On 25 Dec, 2019
On 24 Dec, 2019
Posted 30 Jul, 2019
On 30 Nov, 2019
Received 10 Nov, 2019
Received 10 Nov, 2019
On 26 Oct, 2019
Received 23 Sep, 2019
On 22 Sep, 2019
On 20 Sep, 2019
Invitations sent on 11 Sep, 2019
On 08 Aug, 2019
On 25 Jul, 2019
On 06 Jun, 2019
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
On 30 Jan, 2020
On 13 Jan, 2020
Received 11 Jan, 2020
Invitations sent on 06 Jan, 2020
On 06 Jan, 2020
On 06 Jan, 2020
Received 06 Jan, 2020
On 25 Dec, 2019
On 24 Dec, 2019
Posted 30 Jul, 2019
On 30 Nov, 2019
Received 10 Nov, 2019
Received 10 Nov, 2019
On 26 Oct, 2019
Received 23 Sep, 2019
On 22 Sep, 2019
On 20 Sep, 2019
Invitations sent on 11 Sep, 2019
On 08 Aug, 2019
On 25 Jul, 2019
On 06 Jun, 2019
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 and design
430 participants with IBS-D will be recruited 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.
Figure 1
Figure 2