Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

Abbott Nutrition32 sites in 1 country366 target enrollmentSeptember 30, 2019

ConditionsGrowth and Tolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth and Tolerance
Sponsor: Abbott Nutrition
Enrollment: 366
Locations: 32
Primary Endpoint: Weight
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.

Registry

clinicaltrials.gov

Start Date

September 30, 2019

End Date

December 4, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant is judged to be in good health as determined from participant's medical history.
•Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
•Participant's birth weight was \> 2490 g (\~5 lbs. 8 oz.).
•Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
•Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
•Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
•Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
•Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria

•An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
•Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
•Participant participates in another study that has not been approved as a concomitant study.