Tolerance of Healthy Infants Fed Infant Formulas

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.

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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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Phase 1-Arm 1 Infant Formula

Milk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum.

Group Type EXPERIMENTAL

Phase 1- Arm 1 Infant Formula

Intervention Type OTHER

Powder infant formula

Phase 2- Arm 2 Infant Formula

Milk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum.

Group Type ACTIVE_COMPARATOR

Phase 2- Arm 2 Infant Formula

Intervention Type OTHER

Powder infant formula

Phase 2- Arm 3 Infant Formula

Milk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum.

Group Type EXPERIMENTAL

Phase 2- Arm 3 Infant Formula

Intervention Type OTHER

Powder infant formula

Interventions

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Phase 1- Arm 1 Infant Formula

Powder infant formula

Intervention Type OTHER

Phase 2- Arm 2 Infant Formula

Powder infant formula

Intervention Type OTHER

Phase 2- Arm 3 Infant Formula

Powder infant formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Singleton from a full term birth with a gestational age of 37-42 weeks.
* Birth weight was \> 2490 g (\~5 lbs 8 oz).
* Age between 0 and 30 days at enrollment.
* Agreement to discontinue the use of medications (including over the counter \[OTC\], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
* Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
* Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
* Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria

* An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant treated with antibiotics.
* Participation in another study that has not been approved as a concomitant study by AN.

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No