Status:
TERMINATED
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Lead Sponsor:
Mead Johnson Nutrition
Conditions:
Gastrointestinal Microbiome
Eligibility:
All Genders
7-18 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04059666
Start Date
March 5 2019
End Date
February 2 2022
Last Update
August 25 2022
Active Locations (5)
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1
Birmingham Pediatric Associates
Birmingham, Alabama, United States, 35205
2
Children's Research, LLC
Altamonte Springs, Florida, United States, 32701
3
Owensboro Pediatrics
Owensboro, Kentucky, United States, 42303
4
Holston Medical Group
Kingsport, Tennessee, United States, 37660