Cow's Milk Allergy
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Cow's Milk Allergy
V1605-201 Enrolling

Research Trial for Cow’s Milk Allergy in Children (3 Months)


Treatment: Topical Age: 29 Days

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.


The following information is from ClinicalTrials.gov

Last Update Posted: January 29, 2023

Official Title

A Phase 2 Study to Evaluate the Sensitivity, Specificity and Safety of DBV1605, a Ready-to-Use Atopy Patch Test for the Diagnosis of Non-Immunoglobulin E Mediated Cow's Milk Allergy in Children

ClinicalTrials.gov ID

NCT04492683

Sponsor

DBV Technologies

Study Description

  • 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: DBV1605
    Combination Product: DBV1605
  • Phase:

    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
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Mariam Hanna

Pediatric Dermatologist

Dr. Douglas Mack

Pediatric Allergist

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