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Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia
Paul Rahden1,2, Abdoulie Fatty1, Momodou Lamin Jobarteh1
1Department of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, Gambia.
Insights
This feasibility study suggests polymethylsiloxane polyhydrate may reduce diarrhoea duration in children. Further trials are needed to confirm its effectiveness in treating acute paediatric diarrhoea.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
Background:
- Diarrhoea is a major cause of childhood mortality globally.
- Intestinal adsorbents offer a potential therapeutic approach to reduce diarrhoea duration and severity.
Purpose of the Study:
- To assess the feasibility of a randomized controlled trial for polymethylsiloxane polyhydrate in acute paediatric diarrhoea.
- To evaluate the preliminary efficacy of polymethylsiloxane polyhydrate as an adjunct to standard treatment.
Main Methods:
- A 2-phase (double-blind, then open-label) randomized feasibility trial was conducted.
- 50 children (6-59 months) with acute diarrhoea received standard care with or without polymethylsiloxane polyhydrate.
- The primary outcome was time to the last watery stool.
Main Results:
- The study demonstrated feasibility, with rapid recruitment and high completion rates.
- Children receiving polymethylsiloxane polyhydrate experienced a significantly shorter time to the last watery stool (-19.3 hours).
- Reduced stool frequency was observed in the intervention group on days 2 and 3.
Conclusions:
- A randomized controlled trial for polymethylsiloxane polyhydrate in acute diarrhoea is feasible.
- Polymethylsiloxane polyhydrate shows promise in reducing diarrhoea duration and severity in children.
- Further clinical trials are warranted to confirm efficacy and inform treatment guidelines.
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.
