NCT04059666
Terminated
Not Applicable
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Mead Johnson Nutrition5 sites in 1 country57 target enrollmentMarch 5, 2019
ConditionsGastrointestinal Microbiome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrointestinal Microbiome
- Sponsor
- Mead Johnson Nutrition
- Enrollment
- 57
- Locations
- 5
- Primary Endpoint
- Comparison of stool microbiome between breast fed and formula fed babies
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Comparison of stool microbiome between breast fed and formula fed babies
Time Frame: Over 60 days
Stool collection
Secondary Outcomes
- Stool molecules at each visit(Over 60 days)
- Stool color and consistency(3 times over 60 days)
- Oral microbiome at each visit(Over 60 days)
- 24 hour recall of formula intake(2 times over 60 days)
- Medically confirmed adverse events(60 days)
- Stool pH(Over 60 days)
Study Sites (5)
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