An interventional study of Control infant formula and Test infant formula in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 8 sites in United States. Open to participants aged 11 Days to 17 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-04.
Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable and Interventional
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.
Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
partially hydrolyzed whey infant formula
Other: Control infant formula
partially hydrolyzed whey infant formula with probiotic
Other: Test infant formula
partially hydrolyzed whey infant formula consumed ad libitum throughout study
partially hydrolyzed whey formula with probiotic
growth
weight gain assessed monthly
Time frame: 4 months
other growth
Length, head circumference will be measured at monthly visits
Time frame: 4 months
adverse events
all adverse events will be documented throughout the study
Time frame: 4 months
stool characteristics
stool frequency, color, consistency
Time frame: throughout study
spit-up
frequency of spit-up as reported by caregivers
Time frame: throughout study
vomit
frequency of vomitting as reported by caregivers
Time frame: throughout study
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN) →