Gastrointestinal Tolerance of Formula Supplemented With Prebiotics

Abbott Nutrition10 sites in 1 country131 target enrollmentJanuary 2015

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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.