Infants Fed a Hydrolyzed Infant Formula

Study Overview
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Brief Summary
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The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.

Official Title
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Tolerance of Infants Fed a Hydrolyzed Infant Formula

Conditions
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Gastrointestinal Tolerance

Intervention / Treatment
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* Other: Hydrolyzed protein infant formula with oligosaccharides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant is 0 to 90 days of age at enrollment. Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study. Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study Exclusion Criteria: An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development Awareness of a positive drug screen in the mother or participant Suspected maternal substance abuse including alcohol Participation in another study that has not been approved as a concomitant study by AN Participant is receiving oral or inhaled steroids Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent Participant has received an amino acid-based formula

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Product<br>Infant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz. | Other: Hydrolyzed protein infant formula with oligosaccharides<br>* Hydrolyzed protein infant formula with oligosaccharides<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Maintenance | Change in weight for age z-score | Study Day1 to Study Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerance | Parent completed diary | Study Day1 to Study Day 28 | 
| Weight | Weight gain per day in grams | Study Day1 to Study Day 28 | 
| Length | Length gain per day in cm | Study Day1 to Study Day 28 |