Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
DBV Technologies
Age
0–2
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
DISEASE GROUP
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.
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
You may not be if
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
Subjects with history of persistent gastro-intestinal symptoms
Exclusively breast-fed subjects at Screening visit
Clareo Health | Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
