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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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30 March 2015 |
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Main ID: |
NCT01985607 |
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Date of registration:
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08/11/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of a New Thickened Extensively Hydrolyzed Formula
ALLAR |
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Scientific title:
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Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01985607 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Greece
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Kuwait
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Lebanon
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Slovenia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- term born infants
- Having a Vandenplas' score of regurgitation of at least 2
- With suspected diagnosis of CMA because of clinical history/symptoms (based on a
Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive
Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test
Exclusion Criteria:
- Exclusively breast fed infants
- Fed with an extensively hydrolysed formula or amino acid formula
Age minimum:
N/A
Age maximum:
6 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cow's Milk Protein Hypersensitivity
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Protein Allergy
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Intervention(s)
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Dietary Supplement: Extensively hydrolysed formula
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Dietary Supplement: new extensively hydrolysed formula
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Primary Outcome(s)
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Number of patient dropped out for intolerance
[Time Frame: 1 month]
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Vandenplas' regurgitations score
[Time Frame: 1 month]
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Secondary Outcome(s)
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Growth (weight, height, head circumference)
[Time Frame: 1 month]
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Growth (weight, height, head circumference)
[Time Frame: 3 months]
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Growth (weight, height, head circumference)
[Time Frame: 6 months]
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Cow's milk protein hypersensitivity score
[Time Frame: 1 month]
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Number of daily regurgitations
[Time Frame: 1 month]
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Secondary ID(s)
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UP08-ALLAR
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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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