Healthy Term Infants Fed Milk-Based Infant Formula

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

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 Overview

• Status: Completed
• Conditions: Tolerance
• Intervention / Treatment: Other: Control Infant Formula; Other: Experimental Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research
  • Florida
    • Tampa, Florida, United States, 33613
      • PAS Research, LLC
  • Kentucky
    • Owensboro, Kentucky, United States, 43203
      • Springs Medical Research
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Institute of Clinical Research
    • Westlake, Ohio, United States, 44145
      • The Cleveland Pediatric Research Center, LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Midsouth Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Infant Formula; Feed ad libitum	Other: Control Infant Formula; Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide
Experimental: Experimental Infant Formula; Feed ad libitum	Other: Experimental Infant Formula; Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean rank stool consistency (MRSC)	Parent Completed Diary	Study Day 1 to 28 Days of Age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Interval weight gain per day	14 to 119 Days of Age
Gastrointestinal tolerance	Parent Completed Diary	14 to 119 Days of Age
Length	Interval length gain per day	14 to 119 Days of Age
Head Circumference	Interval head circumference gain per day	14 to 119 Days of Age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Stool Characteristics	Parent Completed Diary	Study Day 1 to 119 Days of Age
Study Product Intake	Parent Completed Diary	Study Day 1 to 119 Days of Age
Infant and Household Characteristics	Parent reported lifestyle and illness questions	Study Day 1 to 119 Days of Age
Health Resource Utilization	Number of Visits	Study Day 1 to 119 Days of Age
Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction	Exit or 119 Days of Age
Infant Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5-point Likert scale questions; scaled in the negative direction	Exit or 119 Days of Age
Formula Satisfaction Questionnaire	Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction	Exit or 119 Days of Age
Adverse Events	Standard adverse event reporting	Study Day 1 to 119 Days of Age

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: John Lasekan, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2020
• Primary Completion (Actual): June 18, 2021
• Study Completion (Actual): June 18, 2021

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AL39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No