Healthy Term Infants Fed Milk-Based Infant Formula

Abbott

Status

Completed

Conditions

Tolerance

Treatments

Other: Experimental Infant Formula

Other: Control Infant Formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT04529759

AL39

Details and patient eligibility

About

This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

Enrollment

108 patients

Sex

All

Ages

Under 14 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Good health as determined from participant's medical history
Singleton from a full-term birth with a gestational age of 37-42 weeks
Birth weight was > 2490 g (~5 lbs. 8 oz.)
Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
Parent(s) confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study
Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study

Exclusion criteria

An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
Participant is enrolled in another study that has not been approved as a concomitant study