Fecal Microbiota
Conditions
Brief summary
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
Detailed description
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
Interventions
OTHERAmino acid based infant formula
OTHERMother's own breast milk
Sponsors
Midwest Children's Health Research Institute
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, 1-7 days of age at registration or randomization * Term infant with appropriate birth weight for gestational age * Either solely formula fed or exclusively receiving mother's own breast milk * Signed Informed Consent and Protected Health Information
Exclusion criteria
* Caesarean delivery * Infant was born from a mother with Type 1 diabetes * History of underlying metabolic or chronic disease or immunocompromised * Feeding difficulties or history of formula or human milk intolerance * Signs of acute infection of current use of antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiota measured at each visit | 8 weeks | Sequencing and composition of samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body length measured at each visit | 8 weeks | Measurement collected with a standardized length board |
| Head circumference measured at each visit | 8 weeks | Measurement collected with a standardized measuring tape |
| Body weight measured at each visit | 8 weeks | Measurement collected with a calibrated infant scale |
| Stool collection at each visit | 8 weeks | Composite measure of pH and short chain fatty acids |
| Serious adverse events collected throughout the study period | 8 weeks | — |
| Parental recall of formula intake at each visit | 8 weeks | — |
Countries
United States
Outcome results
None listed