Eosinophilic Esophagitis

Researchers are developing and validating a wearable sensor designed to help patients with Parkinson's Disease (PD) who have swallowing difficulties and drooling problems. This study focuses on improving the device's battery life and size, assessing usability with patient feedback, and testing its ability to detect and encourage swallowing in PD patients. The aim is to provide a digital therapeutic platform that can support swallowing function in this population. The wearable device, called the Aria sensor, is a patch that monitors physiological signals continuously and provides vibratory haptic cues to increase how often participants swallow. Participants will use the sensor for three weeks, with the device actively providing haptic cues only during the second week. This single-arm study tracks how the sensor performs in real-life conditions without randomization or blinding. Participants will be involved for three weeks, during which researchers will measure swallow frequency changes, participant adherence to using the haptic cues, and changes in clinical scales related to drooling and swallowing. Assessments include comparing sensor data to a gold standard and evaluating symptom severity before and after the intervention. The study also includes focus groups to gather patient feedback on usability, and safety monitoring is conducted throughout the study period.

Researchers are studying familial hypereosinophilia (FE), a hereditary form of hypereosinophilic syndrome (HES) characterized by elevated eosinophil levels that can damage organs such as the heart and nerves. This observational study aims to understand the natural history, genetic causes, and disease markers of FE by enrolling about 50 individuals from a previously studied family, including both affected and unaffected members. Participants will be categorized into groups based on whether they have peripheral blood eosinophilia. They will undergo yearly clinical evaluations including medical history, physical exams, bloodwork, EKG, echocardiograms, and lung function tests. Adult participants will provide bone marrow samples at the start, and some adults may also participate in leukapheresis sessions where blood is processed to separate components for research. Unaffected family members will provide specimens to help identify genetic causes. Throughout the study, participants will donate blood and tissue samples for research. Assessments include monitoring for eosinophil-related organ damage and immunologic and molecular features of the disease. The primary outcome is the development of eosinophilic end organ manifestations over 30 years. Safety and therapy needs will be managed by clinicians, and the study follows participants indefinitely to track disease progression and markers.

Researchers are conducting a non-interventional, observational study to understand patients in Germany receiving dupilumab for eosinophilic esophagitis (EoE). The study focuses on patients' medical history, socio-demographic and disease characteristics, other related conditions, concurrent therapies, and prior EoE treatments. It also aims to evaluate the long-term effects of dupilumab on disease symptoms and patients' quality of life over a two-year period. Participants in this study are those already prescribed dupilumab by their treating physicians in routine clinical practice; no treatments are administered by the study itself. The study observes dupilumab use patterns, safety, and effectiveness during the two years of follow-up. Patients will be followed for approximately 24 months after starting dupilumab treatment with assessments at multiple timepoints to track changes in symptoms, biopsy results, and quality of life measures. During the study, participants will undergo evaluations including medical history review, clinical symptom assessment, endoscopic scoring, esophageal biopsies, and questionnaires on anxiety, depression, and quality of life. Researchers will also collect data on hospitalizations and sick leave related to EoE. Safety will be monitored throughout, and the total participation time for each person is about two years, within a four-year overall study timeline.

The FARE Patient Registry is a prospective observational study focused on collecting detailed health and basic information about individuals living with food allergies. Its purpose is to encourage open sharing of de-identified data and to support participation in clinical trials, ultimately aiming to advance scientific discoveries related to food allergy causes and contributing factors. This registry does not involve any treatment or interventions but gathers real-world experiences from participants with food allergies. It serves as a platform for the food allergy community to contribute data that can help researchers understand the extent and etiology of food allergies. Participants provide their health information and experiences, which are stored in the registry for ongoing research use. The main outcome measured is the creation of a registry that characterizes food allergies and factors influencing their development. The study is observational, with no interventions, and participation can continue until the study end date in August 2027.

Researchers are evaluating vonoprazan, a drug taken once daily at 20 mg, in adults with eosinophilic esophagitis (EoE), a condition characterized by a high number of eosinophils in the esophagus. The study aims to compare vonoprazan to a placebo to see how many participants achieve a peak eosinophil count below 15 eosinophils per high-power field after 12 weeks of treatment. This phase 2, randomized, double-blind study is sponsored by Phathom Pharmaceuticals, Inc. and involves adult participants who meet specific clinical and diagnostic criteria for EoE. Participants are randomly assigned to receive either vonoprazan 20 mg daily for 12 weeks followed by an additional 12 weeks at the same dose, or placebo for 12 weeks followed by 12 weeks of vonoprazan 20 mg daily. The study is conducted across multiple centers and includes a double-blind design to compare the safety and efficacy of vonoprazan against placebo initially and then evaluate continued treatment effects up to 24 weeks. During the trial, participants will be monitored through various assessments including esophageal biopsies to measure eosinophil counts, electronic diaries documenting dysphagia episodes, and endoscopic scoring for EoE severity. The main outcome is the number of participants achieving reduced eosinophil levels at week 12. Secondary assessments include changes in dysphagia days, endoscopic reference scores, and eosinophil counts from baseline to week 12. Safety and adherence will be tracked throughout the study period, with participant involvement expected for up to 24 weeks.

Researchers are evaluating the safety, effectiveness, and how the body processes EP-104GI, an extended-release fluticasone propionate injectable suspension, in adults with eosinophilic esophagitis (EoE). This Phase 1b/2 study aims to understand the local effects of EP-104GI on disease activity using endoscopic and tissue assessments. About 160 participants will be enrolled across dose escalation and randomized dose optimization phases to identify recommended doses and assess outcomes. Participants will receive EP-104GI or a matching vehicle control through submucosal injections during an esophagogastroduodenoscopy (EGD) procedure at the baseline dosing visit. The dose escalation phase will enroll 27 to 33 participants in different dose cohorts, while the randomized phase will assign about 120 participants to one of two dose levels or vehicle control. Those on vehicle control may switch to EP-104GI after 24 weeks if eligible. Additional substudies may include extended pharmacokinetic follow-up. During the study, participants will attend 8 to 10 visits over approximately 52 weeks, with some having up to 4 extra visits extending to 108 weeks. They will undergo 3 to 5 EGD procedures with biopsies to monitor disease changes and safety. Blood and urine samples will be collected for laboratory tests and drug level measurement. Questionnaires will track symptoms like difficulty swallowing and pain when swallowing. Safety and physical health will be regularly assessed throughout the trial.

Researchers are studying how eosinophils, a type of white blood cell, become activated and their role in immune reactions. Eosinophils often increase with allergies, asthma, parasitic infections, some autoimmune diseases, and rarely tumors, a condition called eosinophilia. While usually without symptoms, eosinophilia can sometimes cause swelling, itching, lung problems, heart disease, or nerve damage due to toxic substances released by these cells. Participants with eosinophil counts above 750/ml or abnormal eosinophil buildup in tissues or skin will have thorough medical exams, blood tests, and possibly additional tests based on age and symptoms. This observational study does not offer experimental treatments but monitors clinical responses and collects blood, bone marrow, tissue, and fluid samples for research. Follow-up includes yearly evaluations and may involve bone marrow biopsies, genetic testing, and leukapheresis for adults. Participants will be involved in detailed clinical evaluations at baseline and annually, with sample collections to study disease mechanisms and immune responses. The study aims to identify causes, biomarkers, and treatment effects on eosinophils. Safety monitoring includes standard care for those needing treatment, while research focuses on immune cell behavior, genetic factors, and long-term effects. Participation duration varies per individual, with ongoing assessments of disease activity and patient-reported outcomes.

Researchers are evaluating a new approach to treating patients with squamous cell carcinoma of the oropharynx who have larger primary tumors (stage T3-T4). This phase II randomized trial compares the current standard chemoradiation treatment with a new method that adapts radiotherapy based on MRI scans taken mid-treatment. The goal is to see if adjusting radiation therapy according to tumor shrinkage seen on MRI can reduce swallowing difficulties measured six months after treatment. Participants will be randomly assigned to one of two groups. The standard care group receives radiotherapy planned at the start of treatment, with adjustments only if major anatomical changes occur. The experimental group receives systematic radiation plan changes guided by mid-treatment MRI scans to target the shrinking tumor. Both groups may also receive chemotherapy as part of their treatment. This study uses advanced MR-Linac technology to enable detailed imaging during therapy. During the study, patients will undergo assessments including patient-reported swallowing function measured six months after treatment using the MD Anderson Dysphagia Inventory. Researchers will also monitor acute and late side effects for up to five years after chemoradiation. The trial includes safety monitoring and statistical review of interim data to ensure appropriate sample size. Participation involves regular clinical visits, imaging, and questionnaires to track treatment effects and quality of life.

This research aims to understand how co-existing health conditions, medical history, and allergy tests affect the results of allergen provocation tests in children. The study includes children from birth up to 18 years old who are being investigated for allergies to foods or antibiotics. It is a prospective observational study conducted at the Hans Christian Andersen Children's Hospital. Participants undergo oral provocation tests where small, increasing amounts of allergens are given to assess allergic reactions. The allergens studied include antibiotics and a variety of common food allergens such as milk, egg, peanut, hazelnut, sesame, wheat, various nuts, soy, fish, shellfish, and poppy seed. Each child is assigned to a group based on the specific allergen they are being tested for. During the study, data on demographics, co-existing conditions, symptoms, skin prick tests, specific IgE levels, and details from the provocation tests are collected and entered into a database. Researchers will assess the relationship between allergy test results and provocation outcomes over a five-year period. Children will be monitored through these evaluations to better understand allergy responses and test effectiveness.

Researchers are studying individuals of all ages with suspected or known inherited genetic diseases related to allergic inflammation and immune dysregulation. This research aims to better understand genetic and immune system factors involved in conditions such as atopic dermatitis, asthma, autoimmune diseases, anaphylaxis, and immunodeficiency. The study includes both affected patients and their family members to explore the underlying causes and mechanisms of these disorders. Participants include patients and their blood relatives who may have disorders affecting allergic inflammation or immune system regulation. The study involves collecting various biological samples such as blood, saliva, hair, fingernail clippings, cord blood, bone marrow, tissue biopsies, and buccal swabs. Researchers may also obtain outside medical records and conduct patient evaluations to support laboratory research into genetic and immunopathogenic factors. During the study, participants provide consent for sample collection and storage for future immune system research. Researchers will analyze these samples alongside clinical data to identify susceptibility traits related to these diseases over a period of up to one year. The study may involve ongoing monitoring, review of medical histories, and correlating clinical findings with laboratory results to improve diagnosis and management of allergic and immune dysregulatory disorders.