NCT02025452

Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Jeffrey Pernica · Academic / Other
• Sex: All
• Age: 2 Months – 60 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Gastroenteritis

Interventions

Type	Name	Description
OTHER	Rapid 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_SUPPLEMENT	Probiotic	Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
OTHER	Placebo	Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-01-01
• Last updated: 2017-03-27

Locations

3 sites across 1 country: Botswana