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

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.

Trial registration number: PACTR202302683128875.

Keywords: Child Health; Gastroenterology; Low and Middle Income Countries.

Figure 1. Schematic study design. 1 Blood samples for electrolytes, kidney function and full blood count. 2 Blood sample for electrolytes and kidney function. ORF, oral rehydration fluid.

Figure 2. CONSORT diagram showing patient flow. CONSORT, Consolidated Standards of Reporting Trials; ITT, intention to treat.