Gastrointestinal Microbiome
Conditions
Brief summary
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
Interventions
OTHERInvestigational
Cow's milk-based Infant Formula with whey protein-lipid concentrate
OTHERControl
Cow's milk-based Infant Formula
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Days to 18 Days
Healthy volunteers
Yes
Inclusion criteria
* 7-18 days of age at Visit 1 * Singleton birth * Gestational age of 37-42 weeks * Birth weight of 2500 g (5 lbs 8 oz) or more * Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study * Signed informed consent and use of PHI for infant and birth mother * Receipt of three protocol-compliant Baseline stool samples Infants receiving formula: * Exclusively receiving infant formula for at least 24 hours prior to randomization * Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period Infants receiving human milk: * Mother has intention to exclusively provide mother's-own breast milk for the duration of the study
Exclusion criteria
* Caesarean delivery * Infant consumption of donor milk prior to randomization/registration * Maternal antibiotic use within 48 hours prior to or at time of delivery * Maternal antibiotic use while providing mother's-own breast milk to infant * Infant use of systemic antibiotics prior to randomization/registration * Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration * Weight at Visit 1 is \<95% of birth weight * Infant use of probiotics * Evidence of significant feeding difficulties * Infant was born large for gestational age * History of underlying metabolic or chronic disease or congenital malformation * Infant is immunocompromised Infants receiving human milk: * Consumption of infant formula from 1 day of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of stool microbiome between breast fed and formula fed babies | Over 60 days | Stool collection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool molecules at each visit | Over 60 days | Stool sample |
| 24 hour recall of formula intake | 2 times over 60 days | 24 hour recall questionnaire |
| Oral microbiome at each visit | Over 60 days | Buccal swab |
| Medically confirmed adverse events | 60 days | Medically confirmed adverse events |
| Stool pH | Over 60 days | pH |
| Stool color and consistency | 3 times over 60 days | Color and consistency |
Countries
United States
Outcome results
None listed