Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2014-05-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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New Extensively Hydrolyzed Formula
Administered in context of oral food challenge and then for 16 weeks.
Experimental Extensively Hydrolyzed Formula
Comparator Formula
Administered in context of oral food challenge and then for 16 weeks.
Active Comparator Formula
Interventions
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Experimental Extensively Hydrolyzed Formula
Active Comparator Formula
Eligibility Criteria
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Inclusion Criteria
* 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 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
13 Years
ALL
No
Sponsors
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Perrigo Nutritionals
INDUSTRY
Responsible Party
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Principal Investigators
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Cindy M Barber, PhD
Role: STUDY_DIRECTOR
Perrigo Nutritionals
Locations
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Carolina Ear Nose and Throat Clinic
Orangeburg, South Carolina, United States
Clinical Research Center of Alabama
Birmingham, Alabama, United States
Arkansas Children's Hosptial
Little Rock, Arkansas, United States
Pediatric Care Medical Group
Huntington Beach, California, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Choc Psf, Amc
Orange, California, United States
Allergy Medical Group of the North Area, INC
Roseville, California, United States
Allergy & Asthma Medical Group and Research Center, APC
San Diego, California, United States
1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers
Centennial, Colorado, United States
Sneeze Wheeze and Itch Associates
Normal, Illinois, United States
Institute for Allergy and Asthma
Chevy Chase, Maryland, United States
Einstein Consulting Services, LLC & Virgo Carter Pediatrics
Silver Spring, Maryland, United States
Clinical Research Institute
Plymouth, Minnesota, United States
Clinical Research Solutions, LLC
Middleburg Heights, Ohio, United States
Allergy, Asthma, and Clinical Research Center
Oklahoma City, Oklahoma, United States
TTS Research
Boerne, Texas, United States
STAAMP Clinical Research
San Antonio, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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PRG-VA-14-001
Identifier Type: -
Identifier Source: org_study_id
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