Optimizing the Management of Acute Diarrhoeal Disease

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

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.

Sponsors & Collaborators

• Grand Challenges Canada

  collaborator OTHER

• BioMérieux

  collaborator INDUSTRY

• BioGaia AB

  collaborator INDUSTRY

• Copan Italia S.A.

  collaborator UNKNOWN

• Botswana-UPenn Partnership

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Hamilton Health Sciences Corporation

  lead OTHER

Principal Investigators

• Jeffrey Pernica, MD · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

2 Months

Max Age

60 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2019-01-31

Completion

2019-02-28

Countries

• Botswana

Study Locations