Infants Fed a 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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-07

Study Completion Date

2023-11-18

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.

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Detailed Description

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Conditions

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Gastrointestinal Tolerance

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 Product

Infant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz.

Group Type EXPERIMENTAL

Hydrolyzed protein infant formula with oligosaccharides

Intervention Type OTHER

Hydrolyzed protein infant formula with oligosaccharides

Interventions

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Hydrolyzed protein infant formula with oligosaccharides

Intervention Type OTHER

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

Minimum Eligible Age

0 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No