Healthy Term Infants Fed Milk-Based Formulas

Stopped early · Not applicable

Conditions studied: Infants

In brief

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.

Key facts

Study ID: NCT02069522
Run by: Abbott Nutrition
People needed: 91
Starts: 2014-02-01
Expected to finish: 2015-02-01
Last updated by the study team: 2015-03-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Tuscon Medical Center — Tuscon, Arizona, United States
Northpoint Pediatrics — Indianapolis, Indiana, United States
Midwest Children's Health Research Institute — Lincoln, Nebraska, United States
MetroHealth Medical Center — Cleveland, Ohio, United States
Dayton Clinical Research — Dayton, Ohio, United States
Institute of Clinical Research — Mayfield Heights, Ohio, United States

Full record on ClinicalTrials.gov

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