Trial reportBMJ paediatrics open2025
Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia.
Trial report in BMJ paediatrics open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDiarrhoea remains a leading cause of death in children. An intestinal adsorbent may reduce diarrhoea duration and severity.
methodsRandomised 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.
resultsRecruitment 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.
conclusionsA 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.
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