Enterosgel® in the treatment of functional abdominal pain in children
Research type
Research Study
Full title
Randomised, placebo-controlled study to assess the safety and efficacy of Enterosgel® in the treatment of functional abdominal pain in children and young people
IRAS ID
356725
Contact name
Stephen J Allen
Contact email
Sponsor organisation
Enteromed Ltd
ISRCTN Number
ISRCTN16474818
Clinicaltrials.gov Identifier
CHIL 68074, NIHR RDN Portfolio
Duration of Study in the UK
1 years, 5 months, 28 days
Research summary
Functional Abdominal Pain has become more common in children and young people. These are defined as “Functional Abdominal Pain Disorders” and include Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine and Functional Abdominal Pain Not Otherwise Specified. There is no cure for these conditions and an important part of management aims to reduce symptoms and improve quality of life.
Enterosgel® is an intestinal adsorbent taken by mouth that binds bacterial toxins, and harmful substances in the gut. In the UK it is used for the treatment of acute diarrhoea and irritable bowel syndrome with diarrhoea, in people of all ages. It has been shown to reduce diarrhoea and improve abdominal pain and other gut symptoms. Enterosgel® is classified as a medical device class II (not as a medicine) because it is not adsorbed by the body and is excreted in the stools. Enterosgel® is available over the counter or on prescription as a gel in a tube or sachet and has no taste.
A recent study suggests that Enterosgel® can improve abdominal pain and diarrhoea in patients with irritable bowel syndrome. However, a study is needed to investigate the potential benefits of Enterosgel® in the treatment of Functional Abdominal Pain Disorders in children.
This study aims to recruit 154 children and young people (age 3-18yrs) to see whether or not Enterosgel® may help with Functional Abdominal Pain. The goal is to investigate whether children can take Enterosgel® and measure if they experience a reduction in their pain symptoms and improvement in their quality of life. The study lasts for 10 weeks and has a baseline phase to collect data on symptoms (2weeks), a double-blind phase where children will take placebo or Enterosgel® (4 weeks), followed by an open label phase where all children will take Enterosgel® for 4 weeks.REC name
HSC REC A
REC reference
25/NI/0085
Date of REC Opinion
2 Jul 2025
REC opinion
Further Information Favourable Opinion