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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
276
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.
The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.
The placebo will be the vegetable oil vehicle and look identical to the probiotic.
Princess Marina Hospital
Gaborone, Botswana
Deborah Retief Hospital
Mochudi, Botswana
Scottish Livingstone Hospital
Molepolole, Botswana
Bamalete Lutheran Hospital
Ramotswa, Botswana
Height z-score (HAZ) adjusted for baseline HAZ
Time frame: 60 days post-enrollment
Mortality
Time frame: 60 days post-enrollment
Weight z-score (WAZ) adjusted for baseline WAZ
Time frame: 60 days post-enrollment
Environmental enteropathy score (EES)
composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin
Time frame: 60 days
Diarrhoea recurrence
Time frame: 60 days after enrolment
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