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Study protocol
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
Anu Kemppinen
Clever Cookie Ltd
Corresponding Author
ORCiD: https://orcid.org/0000-0003-4673-6497
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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.
Keywords
Clinical trial, Diarrhoea, Enterosgel, Intestinal adsorbent, Irritable bowel syndrome, Medical device, Placebo-controlled, Randomised controlled trial
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Peer Review Timeline
CURRENT STATUS: Published
Published
On 30 Jan, 2020
No community comments so far
Editorial decision: Accept
On 13 Jan, 2020
Review #2 received
Received 11 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Reviewer #2 agreed
On 06 Jan, 2020
Review #1 received
Received 06 Jan, 2020
Editor assigned
On 25 Dec, 2019
Submission checks complete
On 24 Dec, 2019
Version 1
Posted 30 Jul, 2019
No comments provided
Editorial decision: Minor revision
On 30 Nov, 2019
Review #3 received
Received 10 Nov, 2019
Review #2 received
Received 10 Nov, 2019
Reviewer #3 agreed
On 26 Oct, 2019
Review #1 received
Received 23 Sep, 2019
Reviewer #2 agreed
On 22 Sep, 2019
Reviewer #1 agreed
On 20 Sep, 2019
Reviewers invited
Invitations sent on 11 Sep, 2019
Editor assigned
On 08 Aug, 2019
Submission checks complete
On 25 Jul, 2019
First submitted
On 06 Jun, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Gastroenterology & Hepatology
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
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
Anu Kemppinen
Clever Cookie Ltd
Corresponding Author
ORCiD: https://orcid.org/0000-0003-4673-6497
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Published
On 30 Jan, 2020
No community comments so far
Editorial decision: Accept
On 13 Jan, 2020
Review #2 received
Received 11 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Reviewer #2 agreed
On 06 Jan, 2020
Review #1 received
Received 06 Jan, 2020
Editor assigned
On 25 Dec, 2019
Submission checks complete
On 24 Dec, 2019
Version 1
Posted 30 Jul, 2019
No comments provided
Editorial decision: Minor revision
On 30 Nov, 2019
Review #3 received
Received 10 Nov, 2019
Review #2 received
Received 10 Nov, 2019
Reviewer #3 agreed
On 26 Oct, 2019
Review #1 received
Received 23 Sep, 2019
Reviewer #2 agreed
On 22 Sep, 2019
Reviewer #1 agreed
On 20 Sep, 2019
Reviewers invited
Invitations sent on 11 Sep, 2019
Editor assigned
On 08 Aug, 2019
Submission checks complete
On 25 Jul, 2019
First submitted
On 06 Jun, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Gastroenterology & Hepatology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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