Healthy Term Infants Fed Milk-Based Infant Formula

Completed · Not applicable

Conditions studied: Tolerance

In brief

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.

Key facts

Study ID

NCT04529759

Run by

Abbott Nutrition

People needed

108

Starts

2020-09-12

Expected to finish

2021-06-18

Last updated by the study team

2021-07-15

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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