Gastrointestinal Tolerance of Infant Formula

Study Overview
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Brief Summary
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The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

Official Title
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Gastrointestinal Tolerance of Formula Supplemented With Prebiotics

Conditions
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Gastrointestinal Tolerance

Intervention / Treatment
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* Other: Experimental 1 Infant Formula
* Other: Experimental 2 Infant Formula
* Other: Reference Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant is judged to be in good health. Infant is a singleton from a full term birth with a gestational age of 37-42 weeks. Infant's birth weight was > 2490 g ( 5 lbs 8 oz.). Infant is between 0 and 8 days of age at enrollment. Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study. Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study. Exclusion Criteria: Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development. Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance. Mother intends to use a combination of breast and formula feeding. Participation in another study that has not been approved as a concomitant study by AN.

Ages Eligible for Study
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Maximum Age: 8 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1 Infant Formula<br>Milk-based infant formula without prebiotics | Other: Experimental 1 Infant Formula<br>* Ready to feed infant formula to be fed ad-libitum<br>|
| Experimental: Experimental 2 Infant Formula<br>Milk-based infant formula with prebiotics | Other: Experimental 2 Infant Formula<br>* Ready to feed infant formula to be fed ad-libitum<br>|
| Other: Human Milk-Fed Reference Group<br>Breast fed infants | Other: Reference Group<br>* Breast fed ad libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Consistency Questionnaire | Questionnaire | Baseline to 35 Days of Age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stools per Day Questionnaire | Questionnaire | Baseline to 35 Days of Age | 
| Feeding Spit Up Questionnaire | Questionnaire | Baseline to 35 Days of Age | 
| Weight | Measured | Baseline to 35 Days of Age | 
| Length | Measured | Baseline to 35 Days of Age | 
| Head Circumference | Measured | Baseline to 35 Days of Age |