NCT02803827

Optimizing the Management of Acute Diarrhoeal Disease

Optimizing the Management of Pediatric Acute Diarrhoeal Disease in Botswana

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Hamilton Health Sciences Corporation · 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. 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.

Conditions

• Acute Gastroenteritis

Interventions

Type	Name	Description
OTHER	Rapid 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.
BIOLOGICAL	Probiotic	The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.
OTHER	Placebo	The placebo will be the vegetable oil vehicle and look identical to the probiotic.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-01-01
• Completion: 2019-02-01
• First posted: 2016-06-17
• Last updated: 2019-02-26

Locations

4 sites across 1 country: Botswana