Growth of Term Infants
Conditions
Brief summary
This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.
Interventions
OTHERAn investigational infant formula containing a probiotic source
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Days to 16 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, 12-16 days of age at randomization * Term infant with birth weight of a minimum of 2500 grams * Solely formula fed * Signed Informed Consent and Protected Health Information
Exclusion criteria
* History of underlying metabolic or chronic disease or immunocompromised * Feeding difficulties or formula intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight measured at each study visit | 3.5 months |
Secondary
| Measure | Time frame |
|---|---|
| Recall of infant formula intake at each study visit | 3.5 months |
| Body length measured at each study visit | 3.5 months |
| Recall of stool consistency measured at each study visit | 3.5 months |
| Medically-confirmed adverse events collected throughout the study period | 3.5 months |
| Parental Study Product Assessment Questionnaire completed at Study Visit 2 | once |
| Head circumference measured at each study visit | 3.5 months |
| Recall of gastrointestinal tolerance measured at each study visit | 3.5 months |
Countries
United States
Outcome results
None listed