Growth and Tolerance of Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

Abbott Nutrition14 sites in 1 country245 target enrollmentAugust 5, 2019

ConditionsInfant Development

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant Development
Sponsor: Abbott Nutrition
Enrollment: 245
Locations: 14
Primary Endpoint: Weight
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.

Registry

clinicaltrials.gov

Start Date

August 5, 2019

End Date

September 20, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant is judged to be in good health
•Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
•Participant's 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
•Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization

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, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
•Participant participates in another study that has not been approved as a concomitant study by AN.
•Participant has an allergy or intolerance to any ingredient in the study product
•Participant has been treated with antibiotics within 1 week prior to enrollment