Clinical trial NCT02317952: Formula for Children With Cow's Milk Allergy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Milk Allergy
Lead sponsor: Perrigo Nutritionals
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 90
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Allergic Reaction
timeFrame: 2 weeks
Secondary outcomes:
measure: Growth
timeFrame: 16 weeks
measure: Growth
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hosptial
state: Arkansas
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Orange
country: United States
facility: Choc Psf, Amc
state: California
city: Roseville
country: United States
facility: Allergy Medical Group of the North Area, INC
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, APC
state: California
city: Centennial
country: United States
facility: 1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers
state: Colorado
city: Normal
country: United States
facility: Sneeze Wheeze and Itch Associates
state: Illinois
city: Chevy Chase
country: United States
facility: Institute for Allergy and Asthma
state: Maryland
city: Silver Spring
country: United States
facility: Einstein Consulting Services, LLC & Virgo Carter Pediatrics
state: Maryland
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma, and Clinical Research Center
state: Oklahoma
city: Orangeburg
country: United States
facility: Carolina Ear Nose and Throat Clinic
state: South Carolina
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: San Antonio
country: United States
facility: STAAMP Clinical Research
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Perrigo Nutritionals
name: Cindy M Barber, PhD
role: STUDY_DIRECTOR
References: