Soy Formula Feedings in Healthy, Term Infants

Efficacy of Soy Formula Feedings in Healthy, Term Infants

This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Active Comparator: Control Infant Formula; Other: Experimental Infant Formula 1; Other: Experimental Infant Formula 2; Other: Experimental Infant Formula 3

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • Illinois
    • Aurora, Illinois, United States, 60506
      • Dreyer Clinic
  • Kentucky
    • Owensboro, Kentucky, United States, 42302
      • T&W Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Park Nicollet Medical Foundation
  • Ohio
    • Canton, Ohio, United States, 44709
      • Clinical Studies, Inc
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Memphis
  • Texas
    • San Antonio, Texas, United States, 78212
      • Child Care Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).
• Health infants reported to be tolerating a milk-based formula (Cohorts).
• Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Infant Formula; Ready-to-Feed (RTF) Soy Infant Formula	Other: Active Comparator: Control Infant Formula; Ready-to-Feed (RTF) Soy Infant Formula
Experimental: Experimental Infant Formula 1; Experimental Ready-to-Feed Soy Formula	Other: Experimental Infant Formula 1; method A phytate reduction and 5% protein hydrolysis
Experimental: Experimental Infant Formula 2; Experimental Ready-to-Feed Soy Formula	Other: Experimental Infant Formula 2; method A phytate reduction and 10% protein hydrolysis
Experimental: Experimental Infant Formula 3; Experimental Ready-to-Feed Soy Formula	Other: Experimental Infant Formula 3; method B phytate reduction and 5% protein hydrolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Characteristics Questionnaire	stool number, consistency, and color	Change from Baseline (Study Day 1) to Study Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula Intake	volume consumed	Change from Baseline (Study Day 1) to Study Day 15
Gastrointestinal Tolerance Questionnaire	Incidence of spit up and vomiting	Change from Baseline (Study Day 1) to Study Day 15
Weight	weight and weight gain	Change from Baseline (Study Day 1) to Study Day 15

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 1992
• Primary Completion (Actual): June 1, 1994
• Study Completion (Actual): June 1, 1994

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: AE58