Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

Study Overview
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Brief Summary
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This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.

Official Title
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Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides

Conditions
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Protein Intolerance

Intervention / Treatment
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* Other: Experimental Hydrolyzed Protein Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding. Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance. 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study. Participant's parent(s) or a legally authorized representative (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. Participant is receiving oral or inhaled steroids. Participant participates in another study that has not been approved as a concomitant study. Participant has an allergy or intolerance to any ingredient in the study product. Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.

Ages Eligible for Study
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Maximum Age: 60 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 Hydrolyzed Protein Infant Formula<br>hydrolyzed protein infant formula powder in cans | Other: Experimental Hydrolyzed Protein Infant Formula<br>* fed ad libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight for Age | Change in weight for age z-score | Study Day 1 to Study Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerance | Parent completed diary questions | Study Day 1 to Study Day 60 | 
| Length | Gain measured in cm | Study Day 1 to Study Day 60 | 
| Head Circumference | Gain measured in cm | Study Day 1 to Study Day 60 |