Elemental Formula Hypoallergenicity

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Food Hypersensitivity	Other: Amino Acid formula; Other: Commercially available Amino Acid Formula	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	37 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
Study Start Date :	April 2012
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: New Amino Acid formula	Other: Amino Acid formula; Amino Acid baby formula
Active Comparator: Control formula; Commercially available Amino Acid infant formula	Other: Commercially available Amino Acid Formula; Hypoallergenic Baby formula

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. occurrence of allergic reactions [ Time Frame: 14 days ]
   occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)

Secondary Outcome Measures :

1. Digestive Tolerance [ Time Frame: one week ]
   gastrointestinal tolerance and formula intake recorded during the open challenge phase.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Months to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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
• Any major gastrointestinal disease or abnormalities other than CMA
• Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
• Immunodeficiency
• Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
• Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
• Unstable asthma
• Severe uncontrolled eczema
• Severe anaphylactic reaction to milk within the last 2 years
• Severe anaphylactic reaction to breastmilk within the last 2 years
• Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
• Currently participating in another clinical trial.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States, 92647
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, United States, 92123
United States, Georgia
Georgia Pollens Clinical Research Centers Inc.
Albany, Georgia, United States, 31707
United States, Illinois
Allergy & Asthma Physicians
Hinsdale, Illinois, United States, 60521
United States, Indiana
Deaconess Clinic, Inc.
Evansville, Indiana, United States, 47713
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
ENT & Allergy Associates
Newburgh, New York, United States, 12550
United States, Texas
TTS Research
Boerne, Texas, United States, 78006
United States, Virginia
Clinical Research Partners
Richmond, Virginia, United States, 25233

Sponsors and Collaborators

Nestlé

Investigators

Principal Investigator:	Anna Nowak-Wegrzyn, MD	Mount Sinai Department of Pediatrics

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nestlé
ClinicalTrials.gov Identifier:	NCT01569776 History of Changes
Other Study ID Numbers:	09.55.PED
First Posted:	April 3, 2012
Last Update Posted:	June 26, 2013
Last Verified:	June 2013

Keywords provided by Nestlé:

Cow milk allergy; CMA

Additional relevant MeSH terms:

Hypersensitivity; Food Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate