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
1 other identifier
interventional
90
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
Typical duration for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 2, 2014
CompletedFirst Posted
Study publicly available on registry
December 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 8, 2017
June 1, 2017
2.2 years
December 2, 2014
June 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Allergic Reaction
2 weeks
Secondary Outcomes (2)
Growth
16 weeks
Growth
16 weeks
Study Arms (2)
New Extensively Hydrolyzed Formula
EXPERIMENTALAdministered in context of oral food challenge and then for 16 weeks.
Comparator Formula
ACTIVE COMPARATORAdministered in context of oral food challenge and then for 16 weeks.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Arkansas Children's Hosptial
Little Rock, Arkansas, 72202, United States
Pediatric Care Medical Group
Huntington Beach, California, 92647, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Choc Psf, Amc
Orange, California, 92868, United States
Allergy Medical Group of the North Area, INC
Roseville, California, 95678, United States
Allergy & Asthma Medical Group and Research Center, APC
San Diego, California, 92123, United States
1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers
Centennial, Colorado, 80112, United States
Sneeze Wheeze and Itch Associates
Normal, Illinois, 61761, United States
Institute for Allergy and Asthma
Chevy Chase, Maryland, 20815, United States
Einstein Consulting Services, LLC & Virgo Carter Pediatrics
Silver Spring, Maryland, 20910, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
Clinical Research Solutions, LLC
Middleburg Heights, Ohio, 44130, United States
Allergy, Asthma, and Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Carolina Ear Nose and Throat Clinic
Orangeburg, South Carolina, 29118, United States
TTS Research
Boerne, Texas, 78006, United States
STAAMP Clinical Research
San Antonio, Texas, 78251, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cindy M Barber, PhD
Perrigo Nutritionals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2014
First Posted
December 17, 2014
Study Start
May 1, 2014
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
June 8, 2017
Record last verified: 2017-06