Acute Gastroenteritis
Conditions
Keywords
diarrhoea, gastroenteritis, rapid diagnostics, probiotics
Brief 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.
Interventions
OTHERRapid diagnostics
Participants will have enteric specimens obtained using a flocked rectal swab, which will be transported in 2 mL Cary Blair medium. These will be tested using the BioMerieux BioFire FilmArray GI panel.
BIOLOGICALProbiotic
The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.
OTHERPlacebo
The placebo will be the vegetable oil vehicle and look identical to the probiotic.
Sponsors
Grand Challenges Canada
BioMérieux
BioGaia AB
Copan Italia S.A.
Botswana-UPenn Partnership
University of British Columbia
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 60 Months
Healthy volunteers
No
Inclusion criteria
* acute diarrhoeal illness (\>= 3 stools in 24 hour period)
Exclusion criteria
* diarrhoeal illness \>=14 days * bloody stool * known inflammatory bowel disease, cystic fibrosis, or malignancy * live in a household with someone else documented to have a bacterial or parasitic enteric infection of defined aetiology * live outside catchment areas * no permanent address * no access to mobile phone * previous participation in this study * nosocomial diarrhoea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height z-score (HAZ) adjusted for baseline HAZ | 60 days post-enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 60 days post-enrollment | — |
| Weight z-score (WAZ) adjusted for baseline WAZ | 60 days post-enrollment | — |
| Environmental enteropathy score (EES) | 60 days | composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin |
| Diarrhoea recurrence | 60 days after enrolment | — |
Countries
Botswana
Outcome results
None listed