A Phase 4 interventional study of Rapid diagnostic and Probiotic in Acute Gastroenteritis, sponsored by Jeffrey Pernica. Completed at 3 sites in Botswana. Open to participants aged 2 Months to 60 Months. Per ClinicalTrials.gov, last updated 2017-03-27.
Sponsored by Jeffrey Pernica · Phase 4, Interventional, and Treatment
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.
243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.
This study's enrollment of 76 is below the median of 126 across 160 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →Jeffrey Pernica is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Rapid diagnostic · Dietary Supplement: Probiotic
Other: Rapid diagnostic · Other: Placebo
Dietary Supplement: Probiotic
Other: Placebo
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.
Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
Height z-score (HAZ) adjusted for initial HAZ
Time frame: 60 days post-enrollment
mortality
Time frame: 60 days post-enrollment
environmental enteropathy score
Time frame: 60 days post-enrollment
duration of diarrhoea
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.
Time frame: estimated average duration ~ 4 days.
Weight z-score (WAZ) adjusted for initial WAZ
Time frame: 60 days after enrolment
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Jeffrey Pernica