Healthy Term Infants Fed Milk-Based Formulas

Abbott

Status

Terminated

Conditions

Infants

Treatments

Other: Investigational Milk-based Formula Containing Carotenoid

Other: Standard Milk-based Formula Containing Carotenoid

Study type

Interventional

Funder types

Industry

Identifiers

NCT02069522

AL13

Details and patient eligibility

About

This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

Enrollment

91 patients

Sex

All

Ages

14 to 28 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Infant is 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 14 and 28 days of age
Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study

Exclusion criteria

An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance