BACKGROUND: Diarrhoea remains a leading cause of death in children. An intestinal adsorbent may reduce diarrhoea duration and severity. METHODS: Randomised controlled feasibility trial with two phases: phase 1 (0-4 hours and double-blind) and phase 2 (up to 5 days and open-label). 50 children aged 6-59 months with acute diarrhoea presenting with no or some dehydration to the emergency paediatric unit and outpatient clinic at Edward Francis Small Teaching Hospital, Banjul, The Gambia were randomised to either standard treatment (oral rehydration fluid and zinc) or standard treatment with polymethylsiloxane polyhydrate for up to 5 days. RESULTS: Recruitment was completed in 7 months. All but one child completed the study. There were no major protocol deviations although patient-held diaries did not collect reliable information. Time from randomisation to the last watery stool (primary outcome) was shorter in the intervention than control arm (mean difference -19.3 hours, 95% CI -30.9 to -7.8). Stool frequency was lower in the intervention arm on days 2 (95% CI -0.8 to -1.3 to -0.3) and 3 (95% CI -0.8; -1.3 to -0.3). One serious event (death) occurred in the control arm. CONCLUSIONS: A randomised, controlled trial is feasible. Further clinical trials are warranted to confirm the efficacy of polymethylsiloxane polyhydrate in acute diarrhoea and inform management guidelines. TRIAL REGISTRATION NUMBER: PACTR202302683128875.

Bioline Products s r o Prague Czech Republic

Department of Clinical Sciences Liverpool School of Tropical Medicine Liverpool UK

Department of Implementation Research Bernhard Nocht Institute for Tropical Medicine Hamburg Germany

Department of Medical Statistics London School of Hygiene and Tropical Medicine London UK

Department of Paediatrics Edward Francis Small Teaching Hospital Banjul Gambia

Enteromed Ltd London UK

Pharmacy Department Edward Francis Small Teaching Hospital Banjul Gambia

Severe Malaria in Children Laboratory Edward Francis Small Teaching Hospital Banjul Gambia

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