Formula for Children With Cow's Milk Allergy

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

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

Study Overview

• Status: Completed
• Conditions: Milk Allergy
• Intervention / Treatment: Other: Experimental Extensively Hydrolyzed Formula; Other: Active Comparator Formula

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hosptial
  • California
    • Huntington Beach, California, United States, 92647
      • Pediatric Care Medical Group
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
    • Orange, California, United States, 92868
      • Choc Psf, Amc
    • Roseville, California, United States, 95678
      • Allergy Medical Group of the North Area, INC
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research Center, APC
  • Colorado
    • Centennial, Colorado, United States, 80112
      • 1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze Wheeze and Itch Associates
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Institute for Allergy and Asthma
    • Silver Spring, Maryland, United States, 20910
      • Einstein Consulting Services, LLC & Virgo Carter Pediatrics
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma, and Clinical Research Center
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Carolina Ear Nose and Throat Clinic
  • Texas
    • Boerne, Texas, United States, 78006
      • TTS Research
    • San Antonio, Texas, United States, 78251
      • STAAMP Clinical Research
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Extensively Hydrolyzed Formula; Administered in context of oral food challenge and then for 16 weeks.	Other: Experimental Extensively Hydrolyzed Formula
Active Comparator: Comparator Formula; Administered in context of oral food challenge and then for 16 weeks.	Other: Active Comparator Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Allergic Reaction	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	Anthropometric measurements of weight in all enrolled subjects.	16 weeks
Growth	Anthropometric measurements of length/height in all enrolled subjects.	16 weeks

Collaborators and Investigators

• Sponsor: Perrigo Nutritionals
• Investigators: Study Director: Cindy M Barber, PhD, Perrigo Nutritionals

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: PRG-VA-14-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No