Probiotic Formula and Infant Growth

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Groups

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control infant formula

partially hydrolyzed whey infant formula

Group Type ACTIVE_COMPARATOR

Control infant formula

Intervention Type OTHER

partially hydrolyzed whey infant formula consumed ad libitum throughout study

test infant formula

partially hydrolyzed whey infant formula with probiotic

Group Type EXPERIMENTAL

Test infant formula

Intervention Type OTHER

partially hydrolyzed whey formula with probiotic

Interventions

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Control infant formula

partially hydrolyzed whey infant formula consumed ad libitum throughout study

Intervention Type OTHER

Test infant formula

partially hydrolyzed whey formula with probiotic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy newborn infant
* Full-term
* Birth weight \> 2500 and \< 4500 g
* 14±3 days of age on enrollment
* Exclusively formula-fed, singleton birth
* Having obtained his/her legal representative's informed consent

Exclusion Criteria

* Known or suspected cow-milk allergy
* Congenital illness or malformation that may affect infant feeding and/or growth
* Significant prenatal and/or postnatal disease
* Any readmission to hospital prior to enrollment
* Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
* Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
* Currently participating in another clinical study
* Cannot be expected to comply with treatment

Minimum Eligible Age

11 Days

Maximum Eligible Age

17 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes