Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
Age: Birth - 24 months
Healthy Subjects: Accepts Healthy Volunteers
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: August 28, 2020
End Date: March 01, 2024
Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA.
- Male or female subjects aged > 28 days to ≤ 24 months at Screening Visit
- Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy
- Subjects with any type of diet containing daily products with cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) prior to Screening Visit or who have started a cow's milk elimination diet not more than 4 weeks prior to Screening Visit,
- Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other mammalian milks (such as sheep and goat's milk) as per study requirements.
- Subjects with an established diagnosis of non-IgE mediated CMA
- Breast-fed subject at Screening Visit
- Subjects with a convincing history of IgE-mediated CMA
- Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula initiated more than 4 weeks prior to Screening Visit.
- Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on the skin.
- Any contraindication to a cow's milk challenge CONTROL GROUP
- Male or female subjects aged > 28 days to ≤ 24 months at Screening visit
- Subjects having no medical history of any type of allergy
- Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 4 weeks prior to Screening visit
- Subjects with history of persistent gastro-intestinal symptoms
- Exclusively breast-fed subjects at Screening visit