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Elemental Formula Hypoallergenicity | Clinical Trials | Clareo Health

COMPLETEDNA

Elemental Formula Hypoallergenicity

Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula

NCT01569776•Société des Produits Nestlé (SPN)

Summary

The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.

Eligibility

Age

0 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Born at term (\>36 weeks gestation)
•2 months to ≤12 years of age at enrollment
•Documented CMA within 6 months prior to enrollment
•Otherwise healthy
•Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
•Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
•Having obtained his/her legal representative's informed consent
•Exclusion:
•Children consuming mother's milk at the time of inclusion and during the trial
•Any chromosomal or major congenital anomalies
+11 more criteria

Locations (9)

Pediatric Care Medical Group, Inc.

Huntington Beach, California, United States

Allergy & Asthma Medical Group and Research Center, A P.C.

San Diego, California, United States

Georgia Pollens Clinical Research Centers Inc.

Albany, Georgia, United States

Allergy & Asthma Physicians

Hinsdale, Illinois, United States

Deaconess Clinic, Inc.

Evansville, Indiana, United States

Mount Sinai Medical Center

New York, New York, United States

ENT & Allergy Associates

Newburgh, New York, United States

TTS Research

Boerne, Texas, United States

Clinical Research Partners

Richmond, Virginia, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

June 26, 2013

Enrollment

ACTUAL participants

Conditions

Food Hypersensitivity

Interventions

Amino Acid formula

OTHER

Commercially available Amino Acid Formula

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Elemental Formula Hypoallergenicity

Inclusion Criteria

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