Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas

Study Overview
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Brief Summary
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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.

Official Title
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Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas

Conditions
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Gastrointestinal Microbiome

Intervention / Treatment
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* Other: Investigational
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 18 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Other: Control<br>* Cow's milk-based Infant Formula<br>|
| Experimental: Investigational<br> | Other: Investigational<br>* Cow's milk-based Infant Formula with whey protein-lipid concentrate<br>|
| No Intervention: Mother's-own Breast Milk<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of stool microbiome between breast fed and formula fed babies | Stool collection | Over 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral microbiome at each visit | Buccal swab | Over 60 days | 
| Stool molecules at each visit | Stool sample | Over 60 days | 
| 24 hour recall of formula intake | 24 hour recall questionnaire | 2 times over 60 days | 
| Stool color and consistency | Color and consistency | 3 times over 60 days | 
| Medically confirmed adverse events | Medically confirmed adverse events | 60 days | 
| Stool pH | pH | Over 60 days |