Gastrointestinal Tolerance
Conditions
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.
Interventions
OTHERExperimental Infant Formula 1
method A phytate reduction and 5% protein hydrolysis
OTHERExperimental Infant Formula 2
method A phytate reduction and 10% protein hydrolysis
OTHERExperimental Infant Formula 3
method B phytate reduction and 5% protein hydrolysis
OTHERActive Comparator: Control Infant Formula
Ready-to-Feed (RTF) Soy Infant Formula
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 9 Weeks
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool Characteristics Questionnaire | Change from Baseline (Study Day 1) to Study Day 15 | stool number, consistency, and color |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Weight | Change from Baseline (Study Day 1) to Study Day 15 | weight and weight gain |
Countries
United States
Outcome results
None listed