Benjamin L. Wright, M.D.

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 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.

This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).

The purpose of this study is to investigate eosinophil activities and interactions with other cell types in vitro to better understand how they contribute to health and disease.  Specifically, we will isolate eosinophils and other white blood cells from peripheral blood and subject them to various stimuli as well as co-culture conditions to examine activities and interactions. 

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 test the hypothesis that detergents induce mucosal barrier impairment and initiate allergic inflammation in the esophagus.  Healthy subjects will be recruited to undergo esophageal string tests and high-resolution esophageal manometry with impedance testing before and after brushing their teeth with a toothpaste that contains the detergent sodium lauryl sulfate (SLS).   Detergent concentrations in saliva and epithelial markers of inflammation from mucosal secretions collected by the string test and mucosal impedance measurements will be collected and readouts will be compared at baseline and after brushing teeth with a toothpaste containing SLS.