Formula for Children With Cow's Milk Allergy
Status
Completed
Conditions
Milk Allergy
Treatments
Other: Active Comparator Formula
Other: Experimental Extensively Hydrolyzed Formula
Details and patient eligibility
About
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.
Enrollment
90 patients
Sex
All
Ages
Under 13 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
90 participants in 2 patient groups
New Extensively Hydrolyzed Formula
Experimental group
Description:
Administered in context of oral food challenge and then for 16 weeks.
Treatment:
Other: Experimental Extensively Hydrolyzed Formula
Comparator Formula
Active Comparator group
Description:
Administered in context of oral food challenge and then for 16 weeks.
Treatment:
Other: Active Comparator Formula
Trial contacts and locations
18
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems