NCT00798382CompletedPhase 2
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 154
- Locations
- 34
- Primary Endpoint
- Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
Study Overview
Brief Summary
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 8 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Infant is judged to be in good health.
- •Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- •Infant's birth weight was > 2490 g (~5 lb 8 oz).
- •Infant is between 0 and 8 days of age at enrollment.
- •Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- •Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant for the duration of the study.
- •Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.
Exclusion Criteria
- •An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Infant has been treated with antibiotics.
- •Infant has received probiotics.
Outcomes
Primary Outcomes
Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
Time Frame: 35 days
Secondary Outcomes
- Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age(35 days)
Investigators
Study Sites (34)
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