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 (RELIEVE IBS-D)

Enteromed Ltd0 sites439 target enrollmentNovember 15, 2017

Overview

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32000822/ (added 19/10/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35760493/ (added 28/06/2022)

Registry

who.int

Start Date

November 15, 2017

End Date

October 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Enteromed Ltd

•Current inclusion criteria as of 04/04/2019:
•1\. Written informed consent
•2\. Irritable Bowel Syndrome with diarrhoea (IBS\-D) according to Rome IV criteria
•3\. Aged 16\-75
•4\. Considered suitable to take part in the study by the consenting doctor/nurse
•5\. Diary completed on at least 11 of 14 days (\=75%) during the screening period
•Previous inclusion criteria from 17/10/2018 to 04/04/2019:
•1\. Written informed consent
•2\. Irritable Bowel Syndrome with diarrhoea (IBS\-D) according to Rome IV criteria
•3\. Aged 18\-75

•Current exclusion criteria as of 07/01/2020:
•1\. Loose stools (BSFS 6 or 7\) on less than 3 days during the 14 days after Screening Visit
•2\. Average abdominal pain \<2\.5 during the 14 days after Screening Visit (scale 0–10: 0 \= no pain; 10 \= worst possible pain)
•3\. Previously diagnosed coeliac disease
•4\. Previously diagnosed Inflammatory Bowel Disease
•5\. Previous bowel cancer or bowel resection
•6\. Other previously known gastrointestinal disorder contributing to the diarrhoea
•7\. Unexplained weight loss
•8\. Unexplained rectal bleeding
•9\. Previous use of Enterosgel®