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
297 participants
INTERVENTIONAL
2010-03-31
2014-10-31
Brief Summary
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Detailed Description
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The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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standard starter infant formula
standard starter infant formula
control standard formula
infant are fed 6 months with this formula
test starter formula
test infant formula
test starter infant formula
infants are fed for 6 months with this starter formula
test starter formula with synbiotics
starter formula with synbiotics and adapted protein levels
test starter infant formula with synbiotics
infant are fed for 6 months with this formula
Interventions
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test starter infant formula
infants are fed for 6 months with this starter formula
test starter infant formula with synbiotics
infant are fed for 6 months with this formula
control standard formula
infant are fed 6 months with this formula
Eligibility Criteria
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Inclusion Criteria
* Full-term (\> 37 weeks gestation)
* Birth weight \> 2500 and \< 4500 g
* 14±3 days of age on enrollment
* Singleton birth
* Infant's mother has elected not to breastfeed prior to enrollment
* Has not received solid foods
* Having obtained his/her legal representative's informed consent
Exclusion Criteria
* Congenital illness or malformation that may affect infant feeding and/or growth
* Significant prenatal and/or postnatal disease
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
* Has received oral or intravenous antibiotic therapy in the last 7 days
* Has received probiotics in the last 7 days
* Currently participating in another clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen)
11 Days
6 Months
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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Michael Cabana, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Institute for Health Policy Studies, University of California
Locations
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UCSF Institute for Health Policy Studies/Pediatrics
San Francisco, California, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Countries
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Other Identifiers
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09.04.INF
Identifier Type: -
Identifier Source: org_study_id