Effect of Formula on Infant Behavior

Abbott

Status

Completed

Conditions

Gastrointestinal Tolerance

Treatments

Other: Infant Formula supplemented with Oligosaccharides

Study type

Interventional

Funder types

Industry

Identifiers

AL19

Details and patient eligibility

About

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Enrollment

69 patients

Sex

All

Ages

7 to 42 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is in good health as determined from subject's medical history by parent report
Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
Subject is between 7 and 42 days of age
Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
Infant is exclusively formula-fed at time of study entry
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
Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

Exclusion criteria

An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
Subject participates in another study that has not been approved as a concomitant study
Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment
Subject has been treated with oral antibiotics within 7 days prior to study enrollment
Mother intends to use a combination of breast and formula feeding