Infant, Newborn
Conditions
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.
Interventions
OTHERsoy protein formula
ad lib for 0-35 days of age
OTHERCommercially available soy formula
ad lib for 0-35 days of age
OTHERSoy formula experimental #2
ad lib for 0-35 days of age
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Days
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age. | 35 days |
Secondary
| Measure | Time frame |
|---|---|
| Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age | 35 days |
Countries
United States
Outcome results
None listed