Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis
NCT ID: NCT02025452
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
76 participants
INTERVENTIONAL
2014-03-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Rapid diagnostics and probiotic
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.
Probiotic
Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
Rapid diagnostics and placebo
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.
Placebo
Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
Delayed diagnostics and probiotic
Probiotic
Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
Delayed diagnostics and placebo
Placebo
Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
Interventions
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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.
Probiotic
Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
Placebo
Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* sepsis, pneumonia, UTI, meningitis requiring empiric antibiotic therapy
* malignancy, IBD
* known link to another patient with diarrhoea of defined aetiology
* transferred in already on antimicrobials
* live outside study area
* children with severe acute malnutrition will be eligible for diagnostic arm but not probiotic arm
2 Months
60 Months
ALL
No
Sponsors
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Grand Challenges Canada
OTHER
BioGaia AB
INDUSTRY
Jeffrey Pernica
OTHER
Responsible Party
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Jeffrey Pernica
Head, Division of Pediatric Infectious Disease
Principal Investigators
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Jeffrey Pernica, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Princess Marina Hospital
Gaborone, , Botswana
Scottish Livingstone Hospital
Molepolole, , Botswana
Bamalete Lutheran Hospital
Ramotswa, , Botswana
Countries
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Other Identifiers
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HHS 13-749
Identifier Type: -
Identifier Source: org_study_id
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