NCT04529759CompletedNot Applicable
Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 108
- Locations
- 6
- Primary Endpoint
- Mean rank stool consistency (MRSC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 14 Days (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Control Infant Formula
Active Comparator
Feed ad libitum
Intervention: Control Infant Formula (Other)
Experimental Infant Formula
Experimental
Feed ad libitum
Intervention: Experimental Infant Formula (Other)
Outcomes
Primary Outcomes
Mean rank stool consistency (MRSC)
Time Frame: Study Day 1 to 28 Days of Age
Parent Completed Diary
Secondary Outcomes
- Weight(14 to 119 Days of Age)
- Gastrointestinal tolerance(14 to 119 Days of Age)
- Length(14 to 119 Days of Age)
- Head Circumference(14 to 119 Days of Age)
Investigators
Study Sites (6)
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