Formula for Children With Cow's Milk Allergy

Milk Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317952
• Other study ID #: PRG-VA-14-001
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: June 7, 2017
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Perrigo Nutritionals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Milk Allergy
• Milk Hypersensitivity

Intervention

Other:
• Experimental Extensively Hydrolyzed Formula

• Active Comparator Formula

Locations

Country	Name	City	State
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	TTS Research	Boerne	Texas
United States	1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers	Centennial	Colorado
United States	Institute for Allergy and Asthma	Chevy Chase	Maryland
United States	Pediatric Care Medical Group	Huntington Beach	California
United States	Arkansas Children's Hosptial	Little Rock	Arkansas
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Clinical Research Solutions, LLC	Middleburg Heights	Ohio
United States	Sneeze Wheeze and Itch Associates	Normal	Illinois
United States	Allergy, Asthma, and Clinical Research Center	Oklahoma City	Oklahoma
United States	Choc Psf, Amc	Orange	California
United States	Carolina Ear Nose and Throat Clinic	Orangeburg	South Carolina
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Allergy Medical Group of the North Area, INC	Roseville	California
United States	STAAMP Clinical Research	San Antonio	Texas
United States	Allergy & Asthma Medical Group and Research Center, APC	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Einstein Consulting Services, LLC & Virgo Carter Pediatrics	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Perrigo Nutritionals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Allergic Reaction		2 weeks
Secondary	Growth	Anthropometric measurements of weight in all enrolled subjects.	16 weeks
Secondary	Growth	Anthropometric measurements of length/height in all enrolled subjects.	16 weeks