Formula for Children With Cow's Milk Allergy



Status:Completed
Conditions:Allergy, Allergy, Neurology
Therapuetic Areas:Neurology, Otolaryngology
Healthy:No
Age Range:Any - 13
Updated:6/9/2017
Start Date:May 2014
End Date:December 2016

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A Double-Blind, Randomized, Crossover Allergy Study of an Experimental Formula Followed by a 16 Week Double Blind Feeding Period to Assess Growth, Safety and Development of Tolerance to Cow's Milk Protein

The purpose of this study is to determine if a new extensively hydrolyzed formula can be
consumed by children with Cow's Milk Allergy.


Inclusion Criteria:

- Good health

- Parent/guardian must be willing to provide informed consent

- Parent/guardian agrees to feed study formula provided

- Confirmation of Cow's Milk Allergy

Exclusion Criteria:

- No clinically significant abnormal findings on medical history, laboratory results,
and physical exam.

- No medications that may interfere with or impact evaluation of the study assessments

- Allergy to extensively hydrolyzed casein formula

- Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products
containing intact cow's milk protein within 2 weeks of the Screening Visit

- Participation in another clinical trial within 30 days of screening where they are
are receiving an active intervention
We found this trial at
18
sites
San Antonio, Texas 78251
Principal Investigator: Erika Gonzalez, MD
Phone: 210-451-9911
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Jonathan Tam, MD
Phone: 323-361-4537
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Birmingham, Alabama 35209
Principal Investigator: Maxcie Sikora, MD
Phone: 205-209-4100
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Birmingham, AL
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Boerne, Texas 78006
Principal Investigator: Richard Martinez, MD
Phone: 830-249-3602
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Boerne, TX
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Centennial, Colorado 80112
Principal Investigator: Joe L Williams, MD
Phone: 303-771-9000
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Centennial, CO
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Chevy Chase, Maryland 20815
Principal Investigator: Athena Economides, MD
Phone: 301-986-9262
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Chevy Chase, MD
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Huntington Beach, California
Principal Investigator: Paul Qaqundah, MD
Phone: 714-842-1441
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Huntington Beach, CA
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Little Rock, Arkansas 72202
Principal Investigator: Robert Pesek, MD
Phone: 501-364-2391
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Little Rock, AR
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Middleburg Heights, Ohio 44130
Principal Investigator: John Panuto, MD
Phone: 440-340-9010
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Middleburg Heights, OH
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Normal, Illinois 61761
Principal Investigator: Dareen Siri, MD
Phone: 309-452-0995
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Normal, IL
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Oklahoma City, Oklahoma 73120
Principal Investigator: Martha Tarpay, MD
Phone: 405-752-0393
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Oklahoma City, OK
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Orange, California 92868
Principal Investigator: Sherwin Gillman, MD
Phone: 714-633-6363
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Orange, CA
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Orangeburg, South Carolina 29118
Principal Investigator: John Ansley, MD
Phone: 803-536-0636
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Orangeburg, SC
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Plymouth, Minnesota 55441
Principal Investigator: Allan Stillerman, MD
Phone: 763-744-1140
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Plymouth, MN
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Roseville, California 95678
Principal Investigator: Sunil Perera, MD
Phone: 916-782-7758
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Roseville, CA
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San Diego, California 92123
Principal Investigator: Michael Welch, MD
Phone: 858-268-2368
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San Diego, CA
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: David Naimi, DO
Phone: 206-525-5520
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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Silver Spring, Maryland 20910
Principal Investigator: Gabrielle Virgo, MD
Phone: 301-275-5571
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Silver Spring, MD
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