Status:
COMPLETED
Healthy Term Infants Fed Milk-Based Infant Formula
Lead Sponsor:
Abbott Nutrition
Conditions:
Tolerance
Eligibility:
All Genders
Up to 14 years
Phase:
NA
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04529759
Start Date
September 12 2020
End Date
June 18 2021
Last Update
July 15 2021
Active Locations (6)
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1
Visions Clinical Research
Tucson, Arizona, United States, 85712
2
PAS Research, LLC
Tampa, Florida, United States, 33613
3
Springs Medical Research
Owensboro, Kentucky, United States, 43203
4
Institute of Clinical Research
Mentor, Ohio, United States, 44060