Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's
Milk Allergy in Children
Research Question:
Does a patch, called DBV1605, help diagnose cow's milk allergies when applied to children's
skin?
Basic Study Information
Purpose:
Food allergy represents a major public health concern affecting approximately 8% of
children and 5% of adults. Cow's milk allergy is the most common food allergy in infants
and young children in developed countries. There are no validated tests for the diagnosis
of delayed onset cow's milk allergy. Patients in the Disease group will attend 6
to 7 study visits within 3 months and will have phone calls scheduled with the study
site, each for a period of 5 days. Entire Study participation will be up to 3 months.
A group of children with suspected cow's milk allergy aged from >28 days to ≤24 months
will be considered for participation in the study.
Location: University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
Study Reference #: STUDY00007294
Lead Researcher (Principal Investigator)
Lead Researcher:
Kirsi Jarvinen-seppo
Study Contact Information
Study Coordinator: Allison W. Leadley
Phone: (585) 275-4640
Email: Allison_Leadley@urmc.rochester.edu
Additional Study Details
Number of Visits:
6 to 10
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