Gastrointestinal Tolerance Evaluation of an Infant Formula

Study Overview
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Brief Summary
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Prospective, double-blind, randomized study of 2 infant formulas.

Detailed Description
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Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.

Official Title
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Infant Formula GI Tolerance Evaluation

Conditions
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Healthy, Full-term Infants Who Are Formula-fed

Intervention / Treatment
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* Other: Routine Infant Formula 1
* Other: Routine Infant Formula 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy newborn singleton infant Full-term (> 37 weeks gestation) Birth weight ≥ 2500 grams and ≤ 4500 grams 9-19 days of age on enrollment Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment Having obtained his/her legal representative's informed consent Exclusion Criteria: Known or suspected cow-milk allergy Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula Currently not tolerating (as perceived by the caregiver) their formula Currently being treated for reflux Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu) Congenital illness or malformation that may affect infant feeding and/or growth Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted). Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen). Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.

Ages Eligible for Study
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Minimum Age: 9 Days
Maximum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine Infant Formula 1<br>Routine infant formula with probiotic | Other: Routine Infant Formula 1<br>* Routine infant formula with probiotic<br>|
| Active Comparator: Routine Infant Formula 2<br>Routine infant formula with probiotic and prebiotic | Other: Routine Infant Formula 2<br>* Routine infant formula with probiotic and prebiotic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant GI Symptom Burden | Study personnel will administer questionnaire | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool pattern | Caregivers will document on diary records | 6 weeks | 
| Spit-up and/or vomiting pattern | Caregivers will document on diary records | 6 weeks | 
| Crying and fussing duration | Caregivers will document on diary records | 6 weeks | 
| Formula intake | Caregivers will document on diary records | 6 weeks | 
| Formula satisfaction questionnaire | Study personnel will administer questionnaire | 6 weeks | 
| Weight (measured in grams) | Study personnel will measure | Enrollment and 6 weeks | 
| Length (measured in centimeters) | Study personnel will measure | Enrollment and 6 weeks | 
| Adverse events | Assessed throughout study | 2 weeks and 6 weeks |