Gastrointestinal Tolerance of Infant Formula

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

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

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Detailed Description

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Conditions

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Gastrointestinal Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental 1 Infant Formula

Milk-based infant formula without prebiotics

Group Type EXPERIMENTAL

Experimental 1 Infant Formula

Intervention Type OTHER

Ready to feed infant formula to be fed ad-libitum

Experimental 2 Infant Formula

Milk-based infant formula with prebiotics

Group Type EXPERIMENTAL

Experimental 2 Infant Formula

Intervention Type OTHER

Ready to feed infant formula to be fed ad-libitum

Human Milk-Fed Reference Group

Breast fed infants

Group Type OTHER

Reference Group

Intervention Type OTHER

Breast fed ad libitum

Interventions

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Experimental 1 Infant Formula

Ready to feed infant formula to be fed ad-libitum

Intervention Type OTHER

Experimental 2 Infant Formula

Ready to feed infant formula to be fed ad-libitum

Intervention Type OTHER

Reference Group

Breast fed ad libitum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.).
* Infant is between 0 and 8 days of age at enrollment.
* Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Exclusion Criteria

* Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
* Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
* Mother intends to use a combination of breast and formula feeding.
* Participation in another study that has not been approved as a concomitant study by AN.

Maximum Eligible Age

8 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes