Formula for Children With Cow's Milk Allergy

Not Applicable

Completed

• Conditions: Milk Allergy
• Interventions: Other: Experimental Extensively Hydrolyzed Formula; Other: Active Comparator Formula

• 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

Arm && Interventions

Group	Intervention	Description
New Extensively Hydrolyzed Formula	Experimental Extensively Hydrolyzed Formula	Administered in context of oral food challenge and then for 16 weeks.
Comparator Formula	Active Comparator Formula	Administered in context of oral food challenge and then for 16 weeks.

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)

Einstein Consulting Services, LLC & Virgo Carter Pediatrics; 🇺🇸 Silver Spring, Maryland, United States

Arkansas Children's Hosptial; 🇺🇸 Little Rock, Arkansas, United States

Sneeze Wheeze and Itch Associates; 🇺🇸 Normal, Illinois, United States

Allergy, Asthma, and Clinical Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Allergy Medical Group of the North Area, INC; 🇺🇸 Roseville, California, United States

Pediatric Care Medical Group; 🇺🇸 Huntington Beach, California, United States

Clinical Research Institute; 🇺🇸 Plymouth, Minnesota, United States

Choc Psf, Amc; 🇺🇸 Orange, California, United States

STAAMP Clinical Research; 🇺🇸 San Antonio, Texas, United States

Allergy & Asthma Medical Group and Research Center, APC; 🇺🇸 San Diego, California, United States

Clinical Research Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers; 🇺🇸 Centennial, Colorado, United States

Clinical Research Solutions, LLC; 🇺🇸 Middleburg Heights, Ohio, United States

Institute for Allergy and Asthma; 🇺🇸 Chevy Chase, Maryland, United States

TTS Research; 🇺🇸 Boerne, Texas, United States

Carolina Ear Nose and Throat Clinic; 🇺🇸 Orangeburg, South Carolina, United States