Clinical Trials

The purpose of this study is to assess whether dupilumab as an adjunct to milk oral immunotherapy (OIT) compared to placebo improves desensitization and safety, defined as an increase in the proportion of subjects who pass a double-blind placebocontrolled food challenge (DBPCFC) to at least 2040 mg cumulative milk protein at week 18.

Allergic and immunologic disorders are very common but some are very poorly understood. Numerous studies of the epidemiology, characteristics, diagnosis and treatment of these disorders are urgently needed to identify and optimally treat affected patients. Though numerous challenges impact the progress of research in this area, specimens are needed to test new hypotheses and methodologies.  We aim to create a registry and biorepository of tissue and fluid specimens for future studies.

The purpose of this study is to evaluate the contribution of C. albicans to dysbiotic microbial communities of mucosal tissues in pediatric populations. Prospective sampling across multiples tissue sites in a pediatric cohort will be used to assess which tissues are colonized by C. albicans and associated with microbial dysbiosis seen in atopic dermitis.

We hypothesize presence of C. albicans in the microbial communities in early life is associated with atopy. We will assess the presence of C. albicans in the microbial communities of a population of children at-risk for atopic dermatitis compared to healthy controls who do not have an underlying risk for atopy based off family history. In tandem with the collection of human samples, we will utilize mouse models to validate the influence of C. albicans exposure during early life on the systemic immune populations.

The purpose of this study is to build a Mayo Clinic registry of data and biobank from subjects with drug allergy. The data collected will include demographic, diagnostic, and health data on a large group of patients to discover novel drug allergy diagnostic methods.

The aim of this study is to examine the role of mast cell mediators in children with allergic disorders in a two part study. Part 1 of the study will prospectively obtain the values of mast cell mediators, including 2,3 dinor 11β-PGF2α, n-MH, and LTE4 in the urine of a healthy pediatric reference population. Part 2 of the study will prospectively evaluate the urine concentrations of mast cell mediators in a cohort of pediatric allergic disorder patients including asthma, allergic rhinoconjunctivitis, eczema, urticaria, systemic anaphylaxis, and mast cell disorders, as well as POTS (postural orthostatic tachycardia syndrome). Comparisons of these values in the disease cohort will be made utilizing the pediatric expected reference intervals established in Part 1. Further analysis will determine if one or several urine mast cell mediators are elevated in a particular allergic disorder.

The primary objective of this study is to evaluate markers of eosinophilic inflammation in the esophagus longitudinally in subjects on milk oral immunotherapy (OIT) or placebo.

This is a companion study to a parent clinical trial which is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in subjects aged 4 to 50 years inclusive who are allergic to milk. The parent study consists of a screening period, a 24-week treatment period, which includes 4 weeks of pre-treatment with dupilumab or placebo followed by 12 weeks of treatment with dupilumab or placebo in combination with a gradual up-dosing of milk protein OIT, then followed by 8 weeks of milk OIT dosing with no dupilumab or placebo.  This study will examine markers of esophageal inflammation during the parent study using a non-invasive testing device, the esophageal string test (EST).

No dupilumab data will be reported to the FDA for this string test study.

The EnteroTracker® is an FDA-registered and listed Class I, 510(k) exempt medical device which is available for sale and use in the United States.  While is currently marketed for diagnosis and monitoring of EoE, the device (i.e. string test) itself was initially developed and used for detection of giardia infection and collection of duodenal bile and was referred to as the Entero-Test.  Enterotracker® combines the string test device with Lab-Developed Tests (LDTs) for EoE-associated disease biomarkers validated under CAP/CLIA standards (LDTs performed by Cambridge Biomedical Inc. CAP Accreditation (LAP# 7191028) CLIA Accreditation (ID# 22D0926993) FDA Registration (3003006583)).

The purpose of this study is to evaluate the rate of compliance for having an emergency epinephrine autoinjector readily accessible in adults with allergies, and to determine factors that negatively influence adults with allergies for having an emergency epinephrine autoinjector readily accessible.