Soy Formula Feedings in Healthy, Term Infants

Not Applicable

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Experimental Infant Formula 1; Other: Experimental Infant Formula 2; Other: Experimental Infant Formula 3

• Registration Number: NCT02456831
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1992-12
• Primary Completion: 1994-06
• Study Completion: 1994-06
• Status Verified: 2015-05
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-28
• Last Update Submitted: 2015-05-28
• Study First Posted: 2015-05-29
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Infant Formula 1	Experimental Infant Formula 1	Experimental Ready-to-Feed Soy Formula
Experimental Infant Formula 2	Experimental Infant Formula 2	Experimental Ready-to-Feed Soy Formula
Experimental Infant Formula 3	Experimental Infant Formula 3	Experimental Ready-to-Feed Soy Formula

Primary Outcome Measures

Name	Time	Method
Stool Characteristics Questionnaire	Change from Baseline (Study Day 1) to Study Day 15	stool number, consistency, and color

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Dreyer Clinic; 🇺🇸 Aurora, Illinois, United States

T&W Research; 🇺🇸 Owensboro, Kentucky, United States

Clinical Studies, Inc; 🇺🇸 Canton, Ohio, United States

Park Nicollet Medical Foundation; 🇺🇸 Minneapolis, Minnesota, United States

Research Memphis; 🇺🇸 Memphis, Tennessee, United States

Child Care Associates; 🇺🇸 San Antonio, Texas, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States