Soy Formula Feedings in Healthy, Term Infants
Status
Completed
Conditions
Gastrointestinal Tolerance
Treatments
Other: Experimental Infant Formula 1
Other: Experimental Infant Formula 3
Other: Experimental Infant Formula 2
Other: Active Comparator: Control Infant Formula
Details and patient eligibility
About
This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.
Enrollment
115 patients
Sex
All
Ages
2 to 9 weeks old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
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).
Trial design
115 participants in 4 patient groups
Control Infant Formula
Active Comparator group
Description:
Ready-to-Feed (RTF) Soy Infant Formula
Treatment:
Other: Active Comparator: Control Infant Formula
Experimental Infant Formula 1
Experimental group
Description:
Experimental Ready-to-Feed Soy Formula
Treatment:
Other: Experimental Infant Formula 1
Experimental Infant Formula 2
Experimental group
Description:
Experimental Ready-to-Feed Soy Formula
Treatment:
Other: Experimental Infant Formula 2
Experimental Infant Formula 3
Experimental group
Description:
Experimental Ready-to-Feed Soy Formula
Treatment:
Other: Experimental Infant Formula 3
Trial contacts and locations
7
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Data sourced from clinicaltrials.gov
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