Exploratory/Proof of Principle Microbiota Study

Study Overview
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Brief Summary
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This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Detailed Description
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This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Official Title
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Exploratory/Proof of Principle Microbiota Study

Conditions
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Fecal Microbiota

Intervention / Treatment
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* Other: Amino acid based infant formula
* Other: Extensively hydrolyzed casein infant formula
* Other: Mother's own breast milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton, 1-7 days of age at registration or randomization Term infant with appropriate birth weight for gestational age Either solely formula fed or exclusively receiving mother's own breast milk Signed Informed Consent and Protected Health Information Exclusion Criteria: Caesarean delivery Infant was born from a mother with Type 1 diabetes History of underlying metabolic or chronic disease or immunocompromised Feeding difficulties or history of formula or human milk intolerance Signs of acute infection of current use of antibiotics

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 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: Amino acid based infant formula<br> | Other: Amino acid based infant formula<br> <br> |
| Experimental: Extensively hydrolyzed casein infant formula<br> | Other: Extensively hydrolyzed casein infant formula<br> <br> |
| Other: Mother's own breast milk<br> | Other: Mother's own breast milk<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal microbiota measured at each visit | Sequencing and composition of samples | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight measured at each visit | Measurement collected with a calibrated infant scale | 8 weeks | 
| Body length measured at each visit | Measurement collected with a standardized length board | 8 weeks | 
| Head circumference measured at each visit | Measurement collected with a standardized measuring tape | 8 weeks | 
| Parental recall of formula intake at each visit |  | 8 weeks | 
| Stool collection at each visit | Composite measure of pH and short chain fatty acids | 8 weeks | 
| Serious adverse events collected throughout the study period |  | 8 weeks |