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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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12 December 2020 |
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Main ID: |
NCT02246010 |
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Date of registration:
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18/09/2014 |
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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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Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country
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Scientific title:
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Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial. |
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Date of first enrolment:
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July 1, 2015 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02246010 |
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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: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Lebanon
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants on artificial milk formula
- Presenting to the ED or pediatric clinics of the American University of Beirut Medical
Center
- Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24
hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or
without fever, vomiting, mucus or blood per stools).
Exclusion Criteria:
- Exclusively or partially breast-fed infants
- Severe dehydration requiring hospitalization
Age minimum:
2 Months
Age maximum:
18 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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Dietary Supplement: Lactose- free milk
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Primary Outcome(s)
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Diarrhea Duration
[Time Frame: From onset of illness till the day of last diarrheic stool passed.]
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Secondary Outcome(s)
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Illness Visits
[Time Frame: 7 days]
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Parental Satisfaction
[Time Frame: 7 days]
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Weight Loss
[Time Frame: 7 days]
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Hospitalization Rate
[Time Frame: 7 days]
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Secondary ID(s)
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PED.MN.09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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