Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Not Applicable
Terminated
- Conditions
- Gastrointestinal Microbiome
- Registration Number
- NCT04059666
- Lead Sponsor
- Mead Johnson Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 57
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Comparison of stool microbiome between breast fed and formula fed babies Over 60 days Stool collection
- Secondary Outcome Measures
Name Time Method 24 hour recall of formula intake 2 times over 60 days 24 hour recall questionnaire
Stool molecules at each visit Over 60 days Stool sample
Stool color and consistency 3 times over 60 days Color and consistency
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
Trial Locations
- Locations (5)
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
Memphis & Shelby County Pediatric
🇺🇸Memphis, Tennessee, United States
Birmingham Pediatric Associates🇺🇸Birmingham, Alabama, United States