Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

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

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-07-31

Brief Summary

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This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

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Detailed Description

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Conditions

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Cow's Milk Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Interventions

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Amino Acid formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Weight loss within the past 4 weeks
* Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
* Birth weight greater than or equal to 1500 grams
* Solely enteral fed
* Infants with at least one persistent allergy symptom
* No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
* Signed informed consent

Exclusion Criteria

* History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
* Metabolic disease requiring special attention

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No