Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:Any - 4
Updated:8/2/2017
Start Date:April 2015
End Date:June 2017

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Trial Summary
Trial Overview
Inclusion Criteria
Infants/children with cow's milk allergy will take part in 2 double-blinded
placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random
order. If both food challenges are passed, subjects will be asked to consume the Test formula
in an at-home open challenge for 7 days.


Inclusion Criteria:

- Born at term (>36 weeks gestation)

- 2 months to <4 years of age at enrollment

- Documented CMA within 6 months prior to enrollment

- Otherwise healthy

- Having obtained his/her legal representative's informed consent

Exclusion Criteria:

- Children consuming mother's milk at the time of inclusion and during the trial

- Any chromosomal or major congenital anomalies

- Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems
(heart murmurs okay))

- Immunodeficiency

- Receiving free amino acid formula

- Subject who in the Investigator's assessment cannot be expected to adhere to the study
protocol

- Currently participating in another clinical trial.
We found this trial at
8
sites
AeroAllergy
Savannah, Georgia
Principal Investigator: Goodman, MD
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Savannah, GA
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Allergy and Sinus Relief Center/Great Lakes Medical research
Chardon, Ohio 44024
Principal Investigator: Lavi, MD
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mi
from
Chardon, OH
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Atria Clinical Research
Little Rock, Arkansas
Principal Investigator: Badhwar, MD
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mi
from
Little Rock, AR
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Allergy and Asthma Associates of Southern California
Mission Viejo, California 92691
Principal Investigator: Berger, MD
Phone: 949-347-8700
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mi
from
Mission Viejo, CA
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Mt. Sinai
New York, New York 10029
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mi
from
New York, NY
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ENT & Allergy Associates
Newburgh, New York 12550
Principal Investigator: Ponda, MD
Phone: 845-562-5941
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mi
from
Newburgh, NY
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All Children's Hospital
Saint Petersburg, Florida 33701
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mi
from
Saint Petersburg, FL
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Allergy and Asthma Research Institute
Waco, Texas 76712
Principal Investigator: Amar, MD
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mi
from
Waco, TX
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