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
NA
239 participants
INTERVENTIONAL
2016-01-21
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Experimental Infant Formula
Experimental Infant Formula containing a prebiotic
Experimental Infant Formula
Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum
Standard Infant Formula
Standard bovine milk-based term infant formula
Standard Infant Formula
Standard bovine milk-based term infant formula, fed ad libitum
Interventions
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Experimental Infant Formula
Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum
Standard Infant Formula
Standard bovine milk-based term infant formula, fed ad libitum
Eligibility Criteria
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Inclusion Criteria
* Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines
* Infants whose parent(s)/LAR are willing and able to comply with study requirements
* Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study
* Healthy term, singleton infant at birth
* Between 21 to 26 days post-natal age at enrollment visit
* Weight-for-length and head circumference-for-age z-scores \>/= - 3 and \</= +3 according to WHO Child Growth Standards
* Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment
Exclusion Criteria
* Infants receiving complementary foods or liquids
* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
* Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
* Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures
21 Days
26 Days
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Elvira M Estorninos, MD
Role: PRINCIPAL_INVESTIGATOR
Asian Hospital and Medical Center
Locations
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Asian Hospital and Medical Center
City of Muntinlupa, , Philippines
Countries
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Other Identifiers
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14.15.INF
Identifier Type: -
Identifier Source: org_study_id
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