Clinical Trials

The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE (Eosinophilic Esophagitis)

This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.

To determine how the esophagus in active and inactive stages of eosinophilic esophagitis transmit fluids.

The primary objectives of the study by study part are:

Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures, and to inform/confirm the final sample size determination for Part B.

Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures.

Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up ...

The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 24 weeks of open-label extension.

The purpose of this study is to investigate the response rate of dietary therapy in patients with Eosinophilic Esophagitis (EoE) and determine rates of long-term compliance with the food elimination diets (SFED, FFED, step-up), and also to identify patient, clinical, and endoscopic factors that may be associated with increased rates of success in patients undergoing dietary therapy in EoE.

This study will evaluate the role the balloon mucosal impedance may have in diagnosing and monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.

The purpose of this study is to investigate the use of noninvasive ultrasound shear wave elastography and ultrasound blood vessel imaging to evaluate eosinophilic esophagitis.

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.

This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302 extension study. The purpose of this study is to see if BOS is safe and well tolerated over the long-term in adolescents and adults with EoE.

The purpose of this study is to collect stool samples and determine the intestine microbe environment in patients who have active or treated inactive eosinophilic esophagitis.

Are we able to use the EPO staining technique using the sponge ?

The purpose of this study is to assess how many patients with milk triggered EoE can tolerate re-introduction of baked milk, and to determine if there is a threshold amount of straight milk that is tolerated

The purpose of this study is to see if the cytosponge ( a 10 minute, in office procedure that does not require sedation) can be used to replace the 6-10 endoscopies that are routinely performed during the standard of care dietary restriction and food reintroduction trials to manage eosinophilic esophagitis.

This study is aimed at understanding whether oral nitric oxide levels can be used as a non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis (EoE).

Can allergy patch test (APT) predict of dietary therapy in patients with Eosinophilic Esophagitis?

The purpose of this study is to assess the effectiveness of antihistamines in the treatment of eosinophilic esophagitis.

The purpose of this study is to perform RNA (genetic) sequencing on biopsies taken from the esophagus of adult patients who have active eosinophilic esophagitis, and look for potential therapeutic targets.

The purposes of this study are to assess the effectiveness of CC-93538 versus placebo in reducing dysphagia symptoms at 24 weeks, and to assess the effectiveness of CC-93538 versus placebo in reducing esophageal eosinophil counts at 24 weeks.

This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (≥15 years) with EoE. Part A will evaluate the efficacy and safety of APT-1011 3 mg administered HS for the induction of response to treatment (histologic and symptomatic) over 12 weeks. Part B will evaluate histological relapse-free status in patients re-randomized to continue APT-1011 or placebo (active treatment withdrawal) until Week 52.

The study is enrolling ages 15+, however Mayo Clinic will only be enrolling adult patients, 18+.

Whether the cytosponge will be a useful non-invasive tool in evaluating patients with eosinophilic esophagitis?

The purpose of this study is to determine if patients treated with long term maintenance medical therapies have a lowered risk of needing subsequent esophageal dilations, and to determine if there are characteristics (demographic, symptoms at initial dilation, biopsy characteristics) that increase risk of or are associated with needing subsequent dilation therapy.

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

The purpose of this study is to compare the effect of benralizumab 30 mg every 4 weeks (Q4W) with placebo on histologic signs and gastrointestinal symptoms in patients with eosinophilic gastritis and/or gastroenteritis (Part A & B).

The objectives of this study are to validate a patient-reported outcome (PRO) instrument for Eosinophilic gastritis and gastroenteritis (EG/EGE) while providing preliminary effectiveness and safety data (24-week Part A), to provide pivotal efficacy and safety data for EG/EGE for the registration of this indication (24-week Part B), and to provide long-term effectiveness and safety data of benralizumab (Part C) during an open label extension.

Eosinophilic gastritis and gastroenteritis (EG/EGE) ...

Part 1 of the study will retrospectively compare the role of mast cells in children versus adult EoE patients based on the peak mast cell density.  Children with EoE have been shown to have more mast cell mediator-type of symptoms (vomiting, abdominal pain) than that of adults (solid food dysphagia).  We hypothesize a greater peak mast cell density in the esophageal biopsies of children than in adults with EoE. The group (children or adults) which show greater peak mast cell density will be the group for Part 2 of the study.

Part 2 of the study will prospectively compare the role ...

This research is being done to see if the investigators can use the cytosponge or esophacap (depending on availability) to determine if shorter duration SFED (two weeks versus six weeks) would have equal results.

The purposes of this study are to evaluate the effects of Etrasimod on esophageal eosinophilia in adult subjects with active eosinophilic esophagitis (EoE), to evaluate the dose-response relationship of 2 doses of etrasimod versus placebo in adult subjects with active EoE, and to select an etrasimod dose based on efficacy and safety for continued development.

Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.

Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE. APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.

The purpose of this study is to to evaluate the process of eating in patients with active EoE compared to inactive EoE and controls.

The purpose of this interventional study is to test and compare the effectiveness of two elimination diets—the 1-food elimination diet (1FED, milk only) and the 6-food elimination diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.

Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance? And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?

The purpose of this study is to generate open-label, longer-term safety, tolerability, and effectiveness follow-up data in patients with EG and/or EoD who completed Study AK002-016 or Study AK002-012.

Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.

Also evaluate tolerance and safety of oral montelukast in treatment of EE.

Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic esophagitis?

A study of the effectiveness of oral Budesonide suspension in adolescents and adults with eosinophilic esophagitis measuring the histologic response and determining if any decrease in difficult swallowing is achieved.

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 observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected for microscopic analysis. Treatments are then decided based on how the tissue looks. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person ...

The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis.

If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.

This study is being done to store blood cells, genetic material, blood serum and tissue biopsies so that they can be used in laboratory studies now and in the future to find causes of the rare disorder of mast cells and/or eosinophils and factors that may contribute to disease progression and treatment response.

The purpose of this study is to collect data related to patients undergoing diagnostic evaluation and treatment of Gastroesophageal Reflux Disease (GERD) and its associated diseases in multiple academic and community settings.

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 ...