Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia
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...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Paediatrics Open |
| Online Access: | https://bmjpaedsopen.bmj.com/content/9/1/e003133.full |
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| author | Elena Markaryan Matthew Dodd Stephen Allen Carol Howell Angela Allen Paul Rahden Abdoulie Fatty Momodou Lamin Jobarteh Abdoulwahab Sallah Ebrahim Jaiteh Doreen Umoh Fanta Bass Radovan Hnatič |
| author_facet | Elena Markaryan Matthew Dodd Stephen Allen Carol Howell Angela Allen Paul Rahden Abdoulie Fatty Momodou Lamin Jobarteh Abdoulwahab Sallah Ebrahim Jaiteh Doreen Umoh Fanta Bass Radovan Hnatič |
| author_sort | Elena Markaryan |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e4887ae590874454aeba1528fc2e2f4a |
| institution | Kabale University |
| issn | 2399-9772 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Paediatrics Open |
| spelling | doaj-art-e4887ae590874454aeba1528fc2e2f4a2025-02-11T11:45:10ZengBMJ Publishing GroupBMJ Paediatrics Open2399-97722025-01-019110.1136/bmjpo-2024-003133Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The GambiaElena Markaryan0Matthew Dodd1Stephen Allen2Carol Howell3Angela Allen4Paul Rahden5Abdoulie Fatty6Momodou Lamin Jobarteh7Abdoulwahab Sallah8Ebrahim Jaiteh9Doreen Umoh10Fanta Bass11Radovan Hnatič12Research, Enteromed Ltd, London, UK4 Department of Medical Statistics, School of Hygiene and Tropical Medicin, London, UKDepartment of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, Gambia3EnteroMed Ltd, London, UKSevere Malaria in Children Laboratory, Edward Francis Small Teaching Hospital, Banjul, GambiaDepartment of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, GambiaDepartment of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, GambiaDepartment of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, GambiaDepartment of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, GambiaPharmacy Department, Edward Francis Small Teaching Hospital, Banjul, GambiaSevere Malaria in Children Laboratory, Edward Francis Small Teaching Hospital, Banjul, GambiaSevere Malaria in Children Laboratory, Edward Francis Small Teaching Hospital, Banjul, GambiaBioline Products s.r.o, Prague, Czech RepublicBackground 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.https://bmjpaedsopen.bmj.com/content/9/1/e003133.full |
| spellingShingle | Elena Markaryan Matthew Dodd Stephen Allen Carol Howell Angela Allen Paul Rahden Abdoulie Fatty Momodou Lamin Jobarteh Abdoulwahab Sallah Ebrahim Jaiteh Doreen Umoh Fanta Bass Radovan Hnatič Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia BMJ Paediatrics Open |
| title | Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia |
| title_full | Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia |
| title_fullStr | Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia |
| title_full_unstemmed | Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia |
| title_short | Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia |
| title_sort | randomised feasibility study of an intestinal adsorbent in acute diarrhoea in the gambia |
| url | https://bmjpaedsopen.bmj.com/content/9/1/e003133.full |
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