Healthy Term Infants Fed Milk-Based Infant Formula

• ClinicalTrials.gov Identifier: NCT04529759
• Recruitment Status: Completed
• First Posted: August 28, 2020
• Last Update Posted: July 15, 2021
• Sponsor: Abbott Nutrition
• Information provided by (Responsible Party): Abbott Nutrition

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tolerance	Other: Control Infant Formula; Other: Experimental Infant Formula	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides
• Actual Study Start Date: September 12, 2020
• Actual Primary Completion Date: June 18, 2021
• Actual Study Completion Date: June 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Mean rank stool consistency (MRSC) [ Time Frame: Study Day 1 to 28 Days of Age ]
   Parent Completed Diary

Secondary Outcome Measures :

1. Weight [ Time Frame: 14 to 119 Days of Age ]
   Interval weight gain per day
2. Gastrointestinal tolerance [ Time Frame: 14 to 119 Days of Age ]
   Parent Completed Diary
3. Length [ Time Frame: 14 to 119 Days of Age ]
   Interval length gain per day
4. Head Circumference [ Time Frame: 14 to 119 Days of Age ]
   Interval head circumference gain per day

Other Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: up to 14 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Visions Clinical Research

Tucson, Arizona, United States, 85712

United States, Florida

PAS Research, LLC

Tampa, Florida, United States, 33613

United States, Kentucky

Springs Medical Research

Owensboro, Kentucky, United States, 43203

United States, Ohio

Institute of Clinical Research

Mentor, Ohio, United States, 44060

The Cleveland Pediatric Research Center, LLC

Westlake, Ohio, United States, 44145

United States, Tennessee

Midsouth Center for Clinical Research

Memphis, Tennessee, United States, 38116

Sponsors and Collaborators

Abbott Nutrition

Investigators

• Study Chair: John Lasekan, PhD; Abbott Nutrition

More Information

• Responsible Party: Abbott Nutrition
• ClinicalTrials.gov Identifier: NCT04529759
• Other Study ID Numbers: AL39
• First Posted: August 28, 2020
• Last Update Posted: July 15, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No