Enterosgel randomised feasibility study acute diarrhoea children under 5 The Gambia BMJ Paediatrics Open 2025 Allen Rahden significant reduction diarrhoea duration

2025: BMJ Paediatrics: The Gambia Children Study

BMJ Paediatrics Open · 2025

Randomised Feasibility Study of an Intestinal Adsorbent in Acute Diarrhoea in The Gambia

Prof. Stephen Allen  ·  Dr Paul Rahden  ·  BMJ Paediatrics Open  ·  2025

Full citation

Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia.

Rahden P, Allen S et al. BMJ Paediatrics Open 2025. Edward Francis Small Teaching Hospital, Banjul, The Gambia · Liverpool School of Tropical Medicine, Liverpool, UK · Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.

50 children aged 6–59 months enrolled in the trial
Under 5 years old — the age group most at risk from diarrhoea-related mortality worldwide
Significant reduction in duration of diarrhoea vs standard care alone

Why this study matters

Diarrhoea remains one of the leading causes of child mortality worldwide

Acute diarrhoea continues to be one of the leading causes of death in children under five years old globally — particularly in low and middle income countries where access to healthcare is limited and dehydration can rapidly become life-threatening. Finding safe, effective, and practical treatments that can be administered from the very first day of illness is a global health priority.

This randomised feasibility trial, conducted at the Edward Francis Small Teaching Hospital in Banjul, The Gambia, and published in BMJ Paediatrics Open in 2025, investigated whether Enterosgel® — mixed directly into oral rehydration solution — could reduce the duration of acute diarrhoea in young children presenting to emergency and outpatient paediatric services.


Study design

How the trial was conducted

50 children aged 6–59 months presenting with acute diarrhoea and no or some dehydration were enrolled at the emergency paediatric unit and outpatient clinic of Edward Francis Small Teaching Hospital, Banjul, The Gambia. They were randomised to either standard treatment or standard treatment with Enterosgel®.

Trial design at a glance

Phase 1

0–4 hours — double-blind

Initial blinded assessment phase on presentation to hospital.

Phase 2

Up to 5 days — open-label

Extended treatment phase for up to 5 days.

Treatment arm

Standard treatment (oral rehydration fluid and zinc) plus Enterosgel® mixed directly into the oral rehydration solution.

Control arm

Standard treatment alone (oral rehydration fluid and zinc).

Setting

Emergency paediatric unit and outpatient clinic, Edward Francis Small Teaching Hospital, Banjul, The Gambia.


Conclusion

A potentially life-saving finding for children worldwide

The study demonstrated that Enterosgel® can be mixed directly into oral rehydration solution and significantly reduces the duration of diarrhoea in children under 5 years old. Enterosgel® was safe, easy to take, and well tolerated by children throughout the trial.

The ability to mix Enterosgel® directly into oral rehydration solution is a particularly significant finding for low-resource settings — it means no additional equipment, no additional administration steps, and no barrier to compliance for young children and caregivers. Starting treatment from the first day of diarrhoea could be life-saving in populations where rapid deterioration is a real and present risk.

“Enterosgel® can be mixed directly into oral rehydration solution and significantly reduces the duration of diarrhoea in children under 5 years old. The use of Enterosgel® from the first day of diarrhoea can be life saving, as diarrhoea continues to be one of the leading causes of children’s death worldwide.”

Prof. Stephen Allen — Department of Clinical Sciences, Liverpool School of Tropical Medicine


The investigators

About the research team

Authors — BMJ Paediatrics Open 2025

Prof. Stephen Allen

Department of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, Gambia. Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.

Dr Paul Rahden

Department of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, Gambia. Department of Implementation Research, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.

Read the full clinical evidence for Enterosgel®

Including all published clinical trials, NHS Drug Tariff listing, and resources for healthcare professionals and patients.

View the research →
Note for healthcare professionals: This summary is intended for informational purposes. The full article is available via BMJ Paediatrics Open. Enterosgel® is a CE Class IIa registered medical device indicated for acute diarrhoea and diarrhoea associated with IBS-D.

References

  1. Rahden P, Allen S et al. Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia. BMJ Paediatrics Open 2025.
  2. Arasaradnam R, Pandya P, Howell C et al. Enterosgel for the treatment of adults with acute diarrhoea in a primary care setting: a randomised controlled trial. BMJ Open Gastroenterology 2019.
  3. 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
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