ENTOPIC RCT: Now Recruiting: Children with Functional Abdominal Pain
Share
Active Clinical Trial · ISRCTN16474818 · March 2026 – March 2027
ENTOPIC RCT: Testing the Efficacy of Enterosgel® to Relieve Abdominal Pain in Children and Young People with Functional Abdominal Pain Disorder
Chief Investigator: Prof Stephen Allen · Alder Hey Children’s NHS Foundation Trust · Bristol Royal Hospital for Children
Trial status
This is an active, ongoing clinical trial currently recruiting participants. The study runs from March 2026 to March 2027.
Registered on the ISRCTN registry: ISRCTN16474818 · Alder Hey Children’s NHS Foundation Trust and Bristol Royal Hospital for Children, UK.
About the trial
A new virtual clinical trial for children with Functional Abdominal Pain Disorder
Functional Abdominal Pain Disorder (FAPD) is a term covering a group of conditions characterised by chronic or recurrent abdominal pain in children and young people, without an identifiable structural or biochemical cause. It includes Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine, and Functional Abdominal Pain Not Otherwise Specified — conditions that significantly affect quality of life, school attendance, and daily activities.
Treatment options for FAPD in children remain limited. The ENTOPIC RCT — a double-blind, randomised, placebo-controlled virtual clinical trial — is investigating whether Enterosgel® can safely and effectively relieve abdominal pain in children and young people aged 3–18 years with FAPD.
Enterosgel® is an oral intestinal adsorbent — a tasteless gel mixed in water and taken as a drink. It is a medical device available on NHS prescription, in retail pharmacies, and over the counter. It is used for all ages from newborns upwards, and has an established clinical evidence base for safety and efficacy in acute diarrhoea and IBS-D.
Trial design
How the study works
Trial phases — 10 weeks total
2-week baseline phase
Collection of baseline symptom data to establish each participant’s starting point before treatment begins.
4-week double-blind phase
Children are randomised to receive either Enterosgel® or placebo. Neither the participants nor the clinical team know who is receiving which treatment.
4-week open-label phase
All children receive Enterosgel®, allowing assessment of its effects across the full participant group.
The primary goal is to measure whether children experience a reduction in abdominal pain symptoms and an improvement in quality of life. The trial is being run as a virtual clinical trial — following the innovative model pioneered in the RELIEVE IBS-D study — enabling participants to take part from home without needing to attend hospital appointments.
Who can participate
Is your child eligible?
Eligibility criteria
Children and young people aged 3–18 years.
Diagnosed with a Functional Abdominal Pain Disorder: Functional Dyspepsia, IBS, Abdominal Migraine, or Functional Abdominal Pain Not Otherwise Specified.
UK-based. The trial is run virtually — no hospital visits required.
Alder Hey Children’s NHS Foundation Trust and Bristol Royal Hospital for Children.
Safety and risk
A safe option with established evidence
The possible risks of participating are very low. Enterosgel® has an established clinical evidence base of safety and efficacy in this age group and for similar conditions — including the randomised feasibility study in children under 5 with acute diarrhoea in The Gambia, published in BMJ Paediatrics Open (2025), which confirmed Enterosgel® is safe, easy to take, and well tolerated by children.
Enterosgel® is not absorbed into the bloodstream. It is a drug-free medical device that passes through the digestive system, binding harmful substances before being completely expelled. It has no systemic pharmacological effect and no known serious adverse events in clinical trials to date.
The investigator
About the chief investigator
Prof Stephen Allen — Chief Investigator
Department of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, Gambia. Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK. Chief Investigator of the Gambia paediatric diarrhoea feasibility study (BMJ Paediatrics Open, 2025) and the ENTOPIC RCT.
View the full trial registration
The ENTOPIC RCT is registered on the ISRCTN registry. Full trial details, eligibility criteria, and contact information are available via the link below.
View the trial registration →References
- ENTOPIC RCT. Efficacy of Enterosgel to relieve abdominal pain in patients with a Functional Abdominal Pain Disorder. ISRCTN16474818. isrctn.com/ISRCTN16474818
- Rahden P, Allen S et al. Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia. BMJ Paediatrics Open 2025.
- Howell CA et al. Double-blinded randomised placebo controlled trial of enterosgel for the treatment of IBS with diarrhoea (IBS-D). Gut 2022;71:2430–2438. doi:10.1136/gutjnl-2022-327293