Formula for Children With Cow's Milk Allergy

Completed · Not applicable

Conditions studied: Milk Allergy

In brief

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

Key facts

Study ID

NCT02317952

Run by

Perrigo Nutritionals

People needed

90

Starts

2014-05-01

Expected to finish

2016-12-01

Last updated by the study team

2017-06-08

Who can join

Age: any, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Carolina Ear Nose and Throat Clinic — Orangeburg, South Carolina, United States
• TTS Research — Boerne, Texas, United States
• STAAMP Clinical Research — San Antonio, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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