Healthy Term Infants Fed Milk-Based Infant Formula

Not Applicable

Completed

• Conditions: Tolerance
• Interventions: Other: Experimental Infant Formula; Other: Control Infant Formula

• Registration Number: NCT04529759
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-28
• Study Start: 2020-09-12
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Infant Formula	Experimental Infant Formula	Feed ad libitum
Control Infant Formula	Control Infant Formula	Feed ad libitum

Primary Outcome Measures

Name	Time	Method
Mean rank stool consistency (MRSC)	Study Day 1 to 28 Days of Age	Parent Completed Diary

Secondary Outcome Measures

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

Trial Locations

Locations (6)

The Cleveland Pediatric Research Center, LLC; 🇺🇸 Westlake, Ohio, United States

Midsouth Center for Clinical Research; 🇺🇸 Memphis, Tennessee, United States

Springs Medical Research; 🇺🇸 Owensboro, Kentucky, United States

Visions Clinical Research; 🇺🇸 Tucson, Arizona, United States

Institute of Clinical Research; 🇺🇸 Mentor, Ohio, United States

PAS Research, LLC; 🇺🇸 Tampa, Florida, United States