Optimizing the Management of Acute Diarrhoeal Disease
Summary
Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. The investigators will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. The investigators will also be randomizing children to Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a large multi-centre trial following the previous pilot trial.
Timeline
- Start
- 2016-06
- Primary completion
- 2019-01
- Completion
- 2019-02
Outcome
Missed primary endpoint
paper L. reuteri intervention (mean decrease of 0.07 SD, 95% CI -0.22 to 0.08 SD) on adjusted HAZ at 60 days. PMID 35418412 ↗
paper neither a test-and-treat algorithm targeting enteropathogens, nor a 60-day course of L. reuteri DSM 17938, were found to markedly impact linear growth PMID 35418412 ↗
Publications
- Guitor AK, Katyukhina A, Mokomane M, Lechiile K, Goldfarb DM, Wright GD, McArthur AG, Pernica JM. Minimal Impact on the Resistome of Children in Botswana After Azithromycin Treatment for Acute Severe Diarrheal Disease. J Infect Dis. 2024 Jul 25;230(1):239-249. doi: 10.1093/infdis/jiae049.
- Pernica JM, Arscott-Mills T, Steenhoff AP, Mokomane M, Moorad B, Bapabi M, Lechiile K, Mangwegape O, Batisani B, Mawoko N, Muthoga C, Vanniyasingam T, Ewusie J, Lowe A, Bonsu JM, Gezmu AM, Smieja M, Mazhani L, Stordal K, Thabane L, Kelly MS, Goldfarb DM. Optimising the management of childhood acute diarrhoeal disease using a rapid test-and- treat strategy and/or Lactobacillus reuteri DSM 17938: a multicentre, randomised, controlled, factorial trial in Botswana. BMJ Glob Health. 2022 Apr;7(4):e007826. doi: 10.1136/bmjgh-2021-007826.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactobacillus reuteri DSM 17938 | Other / unclassified | 5e+08 unknown | Oral |