Metabolomics
Conditions
Brief summary
The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.
Interventions
OTHERControl: Cow milk-based infant formula
OTHERExperimental 1: Cow milk-based infant formula
Experimental 1: Cow milk-based infant formula with prebiotics
OTHERExperimental 2: Cow milk-based infant formula
Experimental 2: Cow milk-based infant formula with probiotics
OTHERExperimental 3: Cow milk-based infant formula
Experimental 3: Cow milk-based infant formula with prebiotics and probiotics
Sponsors
Beijing Kangchen Technologies
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, 10-14 days of age at registration/randomization * Term infant with birth weight of 2500 grams or more from a vaginal birth * Formula feeding infants must be on formula for at least 3 days * Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study * Signed informed consent
Exclusion criteria
* History of underlying metabolic or chronic disease or immune compromised * Feeding difficulties or formula intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fecal microbiota | 3.5 months |
Secondary
| Measure | Time frame |
|---|---|
| Body Length measured at each study visit | Up to 3.5 months |
| Head circumference measured at each study visit | Up to 3.5 months |
| Body Weight measured at each study visit | Up to 3.5 months |
| Recall of gastrointestinal tolerance questionnaire at each study visit | Up to 3.5 months |
| Medically-confirmed adverse events collected throughout the study period | Up to 3.5 months |
| Recall of infant formula usage at each study visit | Up to 3.5 months |
Countries
China
Outcome results
None listed