The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics

Study Overview
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Brief Summary
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The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.

Official Title
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The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics

Conditions
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Metabolomics

Intervention / Treatment
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* Other: Control: Cow milk-based infant formula
* Other: Experimental 1: Cow milk-based infant formula
* Other: Experimental 2: Cow milk-based infant formula
* Other: Experimental 3: Cow milk-based infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton, 10-14 days of age at registration/randomization Term infant with birth weight of 2500 grams or more from a vaginal birth Formula feeding infants must be on formula for at least 3 days Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study Signed informed consent Exclusion Criteria: History of underlying metabolic or chronic disease or immune compromised Feeding difficulties or formula intolerance

Ages Eligible for Study
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Minimum Age: 10 Days
Maximum Age: 14 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: Cow milk-based infant formula<br>Cow milk-based infant formula | Other: Control: Cow milk-based infant formula<br> <br> |
| Experimental: Experimental 1: Cow milk-based infant formula<br>Cow milk-based infant formula with prebiotics | Other: Experimental 1: Cow milk-based infant formula<br>* Experimental 1: Cow milk-based infant formula with prebiotics<br>|
| Experimental: Experimental 2: Cow milk-based infant formula<br>Cow milk-based infant formula with probiotics | Other: Experimental 2: Cow milk-based infant formula<br>* Experimental 2: Cow milk-based infant formula with probiotics<br>|
| Experimental: Experimental 3: Cow milk-based infant formula<br>Cow milk-based infant formula with prebiotics and probiotics | Other: Experimental 3: Cow milk-based infant formula<br>* Experimental 3: Cow milk-based infant formula with prebiotics and probiotics<br>|
| No Intervention: Human Milk Reference<br>Human Milk Reference | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fecal microbiota |  | 3.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight measured at each study visit |  | Up to 3.5 months | 
| Body Length measured at each study visit |  | Up to 3.5 months | 
| Head circumference measured at each study visit |  | Up to 3.5 months | 
| Recall of infant formula usage at each study visit |  | Up to 3.5 months | 
| Recall of gastrointestinal tolerance questionnaire at each study visit |  | Up to 3.5 months | 
| Medically-confirmed adverse events collected throughout the study period |  | Up to 3.5 months |