Acute Gastroenteritis
Conditions
Keywords
diarrhoea, gastroenteritis, rapid diagnostics, probiotics, sub-Saharan Africa
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. We will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. We will also be randomizing children to probiotic therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a pilot trial, necessary before embarking on a large multi-centre trial.
Interventions
OTHERRapid diagnostic
Specimens from rectal mucosa will be obtained using flocked swabs at enrolment. Those in 'rapid diagnostic' groups will have them tested using multiplex PCR the day of enrolment and participants with treatable pathogens will have antimicrobials provided. Those in 'delayed diagnostic' groups will have the swabs batched at tested at the conclusion of the study, being treated as per standard of care.
DIETARY_SUPPLEMENTProbiotic
Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
OTHERPlacebo
Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
Sponsors
Grand Challenges Canada
BioGaia AB
Jeffrey Pernica
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 non-bloody gastroenteritis
Exclusion criteria
* diarrhoea \> 14 days * sepsis, pneumonia, UTI, meningitis requiring empiric antibiotic therapy * malignancy, IBD * known link to another patient with diarrhoea of defined aetiology * transferred in already on antimicrobials * live outside study area * children with severe acute malnutrition will be eligible for diagnostic arm but not probiotic arm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height z-score (HAZ) adjusted for initial HAZ | 60 days post-enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 60 days post-enrollment | — |
| environmental enteropathy score | 60 days post-enrollment | — |
| duration of diarrhoea | estimated average duration ~ 4 days. | Note that presence of diarrhoea will be checked daily during admission. Total duration of diarrhoea will be verified with the caregiver by telephone 7 days after the participant was discharged home. |
| Weight z-score (WAZ) adjusted for initial WAZ | 60 days after enrolment | — |
Countries
Botswana
Outcome results
None listed