Soy Formula Feedings in Healthy, Term Infants
Not Applicable
Completed
- Conditions
- Gastrointestinal Tolerance
- 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
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
- 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)
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Dreyer Clinic
🇺🇸Aurora, Illinois, United States
T&W Research
🇺🇸Owensboro, Kentucky, United States
Park Nicollet Medical Foundation
🇺🇸Minneapolis, Minnesota, United States
Clinical Studies, Inc
🇺🇸Canton, Ohio, 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