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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02025452 |
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Date of registration:
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28/12/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis
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Scientific title:
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Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02025452 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Botswana
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Contacts
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Name:
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Jeffrey Pernica, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- acute non-bloody gastroenteritis
Exclusion Criteria:
- diarrhoea > 14 days
- 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
Age minimum:
2 Months
Age maximum:
60 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Gastroenteritis
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Intervention(s)
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Other: Placebo
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Dietary Supplement: Probiotic
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Other: Rapid diagnostic
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Primary Outcome(s)
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Height z-score (HAZ) adjusted for initial HAZ
[Time Frame: 60 days post-enrollment]
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Secondary Outcome(s)
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duration of diarrhoea
[Time Frame: estimated average duration ~ 4 days.]
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environmental enteropathy score
[Time Frame: 60 days post-enrollment]
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mortality
[Time Frame: 60 days post-enrollment]
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Weight z-score (WAZ) adjusted for initial WAZ
[Time Frame: 60 days after enrolment]
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Secondary ID(s)
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HHS 13-749
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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