Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children

Status unconfirmed · Phase 2

Conditions studied: Cow's Milk Allergy

In brief

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.

Key facts

Study ID

NCT04492683

Run by

DBV Technologies

People needed

230

Starts

2020-08-28

Expected to finish

2024-03-01

Last updated by the study team

2022-08-11

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify 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
• 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

Where it is running

• Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics — Vilnius, Lithuania (enrolling)
• University of Arizona Health Science — Tucson, Arizona, United States (enrolling)
• Allergy, Asthma & Clinical Research Center — Oklahoma City, Oklahoma, United States (enrolling)
• Halton Pediatric Allergy — Burlington, Ontario, Canada (enrolling)
• Hamilton Allergy — Hamilton, Ontario, Canada (enrolling)
• Azienda Ospedaliera Universitaria Federico II — Naples, Italy (enrolling)
• Azienda Ospedaliera di Padova — Padova, Italy (enrolling)
• UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina — Palermo, Italy (enrolling)
• IRCCS Fondazione Policlinico San Matteo - Pediatria — Pavia, Italy (enrolling)
• Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara — Pisa, Italy (enrolling)
• Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica — Roma, Italy (enrolling)
• Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma — Verona, Italy (enrolling)
• Hospital of Lithuanian University of Health Sciences Kauno Klinikos — Kaunas, Lithuania (enrolling)
• Titan Clinical Research — Phoenix, Arizona, United States (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Biomedical Research, LLC — Miami, Florida, United States (enrolling)
• MedPharmics, LLC - Lafayette — Lafayette, Louisiana, United States (enrolling)
• Massachusets General Hospital — Boston, Massachusetts, United States (enrolling)
• New York University Langone Medical Center — New York, New York, United States (enrolling)
• Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• University of California, Rady Children's Hospital — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Eastern Research Inc. — Hialeah, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.