Gastrointestinal Tolerance of Infant Formula

Abbott

Status

Completed

Conditions

Gastrointestinal Tolerance

Treatments

Other: Experimental 1 Infant Formula

Other: Experimental 2 Infant Formula

Other: Reference Group

Study type

Interventional

Funder types

Industry

Identifiers

AL14

Details and patient eligibility

About

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

Enrollment

131 patients

Sex

All

Ages

Under 8 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.