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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
57
Cow's milk-based Infant Formula with whey protein-lipid concentrate
Cow's milk-based Infant Formula
Birmingham Pediatric Associates
Birmingham, Alabama, United States
Children's Research, LLC
Altamonte Springs, Florida, United States
Owensboro Pediatrics
Owensboro, Kentucky, United States
Holston Medical Group
Kingsport, Tennessee, United States
Comparison of stool microbiome between breast fed and formula fed babies
Stool collection
Time frame: Over 60 days
Oral microbiome at each visit
Buccal swab
Time frame: Over 60 days
Stool molecules at each visit
Stool sample
Time frame: Over 60 days
24 hour recall of formula intake
24 hour recall questionnaire
Time frame: 2 times over 60 days
Stool color and consistency
Color and consistency
Time frame: 3 times over 60 days
Medically confirmed adverse events
Medically confirmed adverse events
Time frame: 60 days
Stool pH
pH
Time frame: Over 60 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Memphis & Shelby County Pediatric
Memphis, Tennessee, United States