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Healthy Term Infants Fed Milk-Based Infant Formula | Clinical Trials | Clareo Health

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Healthy Term Infants Fed Milk-Based Infant Formula

Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides

NCT04529759•Abbott Nutrition

Summary

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (6)

Visions Clinical Research

Tucson, Arizona, United States

PAS Research, LLC

Tampa, Florida, United States

Springs Medical Research

Owensboro, Kentucky, United States

Institute of Clinical Research

Mentor, Ohio, United States

The Cleveland Pediatric Research Center, LLC

Westlake, Ohio, United States

Midsouth Center for Clinical Research

Memphis, Tennessee, United States

Key Dates

Start Date

September 12, 2020

Primary Completion Date

June 18, 2021

Completion Date

June 18, 2021

Last Updated

July 15, 2021

Enrollment

108

ACTUAL participants

Conditions

Tolerance

Interventions

Control Infant Formula

OTHER

Experimental Infant Formula

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Healthy Term Infants Fed Milk-Based Infant Formula

Inclusion Criteria

Exclusion Criteria

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