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
Plymouth, Minnesota 55441
Principal Investigator: Allan Stillerman, MD
Phone: 763-744-1140
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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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Los Angeles, CA
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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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Roseville, California 95678
Principal Investigator: Sunil Perera, MD
Phone: 916-782-7758
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Roseville, CA
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San Antonio, Texas 78251
Principal Investigator: Erika Gonzalez, MD
Phone: 210-451-9911
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San Antonio, TX
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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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