Non-IgE mediated food allergies are caused by a reaction involving other components of the immune system apart from Immunoglobulin E antibodies. The reactions do not appear immediately after the ingestion of the food and usually relate to reactions in the gastrointestinal tract. For this trial, boys and girls aged 1 month to 5 years old with a history of symptoms consistent with non-IgE mediated cow’s milk allergy, may qualify to participate. Children must have two or more gastrointestinal symptoms (vomiting, diarrhea, persistent distress/colic, regurgitation, constipation) that lasted at least 1 week within 1 month prior to screening, OR blood in the stool. Children with any type of diet containing regular cow’s milk protein (e.g. cow’s milk consumption, cow’s milk partial elimination, partially hydrolyzed milk) within 1 month prior to screening, will be considered.
Participants will receive an atopy patch test (APT) for diagnostic use containing 2 patches (active and control) applied to the back for 48 hours. Study product and study-related procedures will be provided at no cost. Reimbursement for study-related expenses will also be provided.
For disease group participants, participation will last up to 3 months and involve about 7 visits to the study centre, plus some phone visits.
Burlington - Halton Pediatric Allergy
The following information is from ClinicalTrials.gov
Last Update Posted: June 04, 2023
NCT04492683
DBV Technologies
Brief Summary:
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.
Condition or Disease:
Cow's Milk Allergy
Intervention/Treatment:
Combination Product: DBV1605Phase:
Phase 2
Ages Eligible for Study:
29 Days and 24 Months (Child)
Sexes Eligible for Study:
All
DISEASE GROUP
Inclusion Criteria:
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.
Exclusion Criteria:
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
Inclusion Criteria:
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
Exclusion Criteria:
Subjects with history of persistent gastro-intestinal symptoms
Exclusively breast-fed subjects at Screening visit
Terms and Conditions – ClinicalTrials.gov
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