Tolerance and Compliance of Infants Fed an 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

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-09-30

Brief Summary

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The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

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Detailed Description

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Conditions

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Infant Gastrointestinal Intolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydrolyzed infant formula

Hydrolyzed infant formula to be fed ad libitum

Group Type EXPERIMENTAL

Experimental Hydrolyzed infant formula

Intervention Type OTHER

Experimental hydrolyzed infant formula to be fed ad libitum

Interventions

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Experimental Hydrolyzed infant formula

Experimental hydrolyzed infant formula to be fed ad libitum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infant is 0 to 180 days of age
* Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
* Infant has not consumed an extensively hydrolyzed infant formula
* Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
* Infant is not receiving steroids.
* 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 through the duration of the study.
* Parent(s) confirm their intention not to administer vitamin or mineral during the study