Soy Formula Feedings in Healthy, Term Infants
Efficacy of Soy Formula Feedings in Healthy, Term Infants
1 other identifier
interventional
115
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 1992
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1992
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 1994
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 1994
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedMay 29, 2015
May 1, 2015
1.5 years
May 27, 2015
May 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Stool Characteristics Questionnaire
stool number, consistency, and color
Change from Baseline (Study Day 1) to Study Day 15
Secondary Outcomes (3)
Formula Intake
Change from Baseline (Study Day 1) to Study Day 15
Gastrointestinal Tolerance Questionnaire
Change from Baseline (Study Day 1) to Study Day 15
Weight
Change from Baseline (Study Day 1) to Study Day 15
Study Arms (4)
Control Infant Formula
ACTIVE COMPARATORReady-to-Feed (RTF) Soy Infant Formula
Experimental Infant Formula 1
EXPERIMENTALExperimental Ready-to-Feed Soy Formula
Experimental Infant Formula 2
EXPERIMENTALExperimental Ready-to-Feed Soy Formula
Experimental Infant Formula 3
EXPERIMENTALExperimental Ready-to-Feed Soy Formula
Interventions
method A phytate reduction and 5% protein hydrolysis
method A phytate reduction and 10% protein hydrolysis
method B phytate reduction and 5% protein hydrolysis
Ready-to-Feed (RTF) Soy Infant Formula
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (7)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Dreyer Clinic
Aurora, Illinois, 60506, United States
T&W Research
Owensboro, Kentucky, 42302, United States
Park Nicollet Medical Foundation
Minneapolis, Minnesota, 55416, United States
Clinical Studies, Inc
Canton, Ohio, 44709, United States
Research Memphis
Memphis, Tennessee, 38119, United States
Child Care Associates
San Antonio, Texas, 78212, United States
Study Officials
- STUDY CHAIR
John Lasekan, MBA, PhD, CCRP
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2015
First Posted
May 29, 2015
Study Start
December 1, 1992
Primary Completion
June 1, 1994
Study Completion
June 1, 1994
Last Updated
May 29, 2015
Record last verified: 2015-05