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

Rahden, Paul, Fatty, Abdoulie, Jobarteh, Momodou Lamin, Sallah, Abdoulwahab, Jaiteh, Ebrahim, Allen, Angela, Umoh, Doreen, Bass, Fanta, Dodd, Matthew, Howell, Carol, Markaryan, Elena, Hnatič, Radovan and Allen, Stephen ORCID: https://orcid.org/0000-0001-6675-249X (2025) 'Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia'. BMJ Paediatrics Open, Vol 9, Issue 1, e003133.

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Abstract

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.

Item Type:	Article
Subjects:	WC Communicable Diseases > Tropical and Parasitic Diseases > WC 698 Parasitic intestinal diseases (General) WS Pediatrics > Diseases of Children and Adolescents > By System > WS 310 Digestive system
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1136/bmjpo-2024-003133
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	26 Feb 2025 12:10
Last Modified:	26 Feb 2025 12:10
URI:	https://archive.lstmed.ac.uk/id/eprint/26059

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