Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-01-07

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.

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Detailed Description

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Conditions

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Protein Intolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Hydrolyzed Protein Infant Formula

hydrolyzed protein infant formula powder in cans

Group Type EXPERIMENTAL

Experimental Hydrolyzed Protein Infant Formula

Intervention Type OTHER

fed ad libitum

Interventions

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Experimental Hydrolyzed Protein Infant Formula

fed ad libitum

Intervention Type OTHER

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.

Maximum Eligible Age

60 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No