Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Status
Terminated
Conditions
Gastrointestinal Microbiome
Treatments
Other: Investigational
Other: Control
Details and patient eligibility
About
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.
Enrollment
57 patients
Sex
All
Ages
7 to 18 days old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
57 participants in 3 patient groups
Control
Active Comparator group
Treatment:
Other: Control
Investigational
Experimental group
Treatment:
Other: Investigational
Mother's-own Breast Milk
No Intervention group
Trial contacts and locations
5
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Data sourced from clinicaltrials.gov
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