ENTEROSGEL IN TREATMENT OF ACUTE DIARRHOEA IN ADULTS
Research type
Research Study
Full title
Randomised, multi-centre study to assess efficacy, tolerability and safety of Enterosgel® in treatment of acute diarrhoea in adults
IRAS ID
199390
Contact name
Preeti Pandya
Contact email
Sponsor organisation
ENTEROMED LTD
Clinicaltrials.gov Identifier
NIHR , GAST 5337
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
Every year several million people in the UK suffer from intestinal infections resulting in acute diarrhoea and other symptoms (i.e. vomiting, nausea). The symptoms usually resolve within a few days, but can be unpleasant. Antidiarrheal medications can slow down the bowel movements, but there is a need for treatments which could reduce the duration of diarrhoea and other symptoms and be used in both children and adults. \n\nIn some European countries, intestinal adsorbents are commonly used for treating diarrhoea. One of these products is Enterosgel®, which is available over-the-counter in the UK and has been reported to adsorb and remove harmful substances like bacterial toxins and allergens from the gut. However, there is limited data in peer-reviewed journals on its efficacy in reducing the duration of diarrhoea and other symptoms associated with intestinal infections. The purpose of this study is therefore to collect more data about the potential benefits of using Enterosgel® in the treatment of acute diarrhoea and associated symptoms. \n\nThis will be a randomised controlled trial in 104 patients recruited from medical practices in England. 52 patients will receive Enterosgel® in addition to standard rehydration treatment and 52 patients will be in the control group and receive only standard rehydration treatment without Enterosgel®.\n\nDuration of the study is 1 week and it will involve attending one study visit at the medical practice, followed by phone calls with the research nurse every morning for the next 7 days. The visit will involve confirmation of eligibility, informed consent and assessment of symptoms and relevant disease history. Patients will also be asked to provide a stool sample and to keep a daily diary about their symptoms and manifestations and use of treatments.\n\nThe study is funded by Bioline Products s.r.o., who are the manufacturer of Enterosgel®.
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0818
Date of REC Opinion
1 Dec 2016
REC opinion
Further Information Favourable Opinion