Formula for Children With Cow's Milk Allergy

Not Applicable

Completed

• Conditions: Milk Allergy

• Registration Number: NCT02317952
• Lead Sponsor: Perrigo Nutritionals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-17
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Incidence of Allergic Reaction	2 weeks

Secondary Outcome Measures

Name	Time	Method
Growth	16 weeks	Anthropometric measurements of length/height in all enrolled subjects.

Trial Locations

Locations (18)

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

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