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Showing 1-20 of 71 trials
NCT05583227
A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).
NCT07112378
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment. The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
NCT04991935
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.
NCT06693531
This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE. Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward. Patient questionnaires will measure the following: * How EoE makes one feel * EoE signs and/or symptoms, eg, how difficult it is to swallow * How EoE affects quality-of-life * How EoE impacts aspects of daily life * How EoE symptoms have changed throughout the study
NCT05199532
The purpose of this study is to learn more about Eosinophilic Gastrointestinal Disorders (EGIDs). With this registry we hope to find out more about the symptoms that patients have during their treatment, the quality of life they have with the diagnosis, what the disease looks like throughout the different treatment methods, and if there is a connection between EGIDs and connective tissue disorders. The goal of this study is to be able to better understand EGIDs and use information gained from all the information collected on this study for more precise treatments in the future. We want to create a large collection of samples, called a biorepository, to learn the most about EGIDs as possible. When the samples are collected, which will occur at procedures directed by your child's doctor as part of their standard of care, they will be stored for an unlimited amount of time to perform experiments on these samples and to gather information about EGIDs
NCT06596252
The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
NCT05606705
This research is being done to see if patients with milk-triggered EoE are able to tolerate baked milk in their diet and if there is a threshold amount of straight milk that is tolerable.
NCT04394351
The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: * To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) * To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE * To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation * To study the effects of dupilumab on the type 2 inflammation gene expression signature * To evaluate the concentration-time profile of functional dupilumab in serum in this population * To assess efficacy of long-term (up to 160 weeks) dupilumab treatment * To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study * To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment * To evaluate the impact of dupilumab treatment on EoE signs and symptoms
NCT02202590
The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.
NCT05095116
This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.
NCT05757856
An open-label phase 2 study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 and NDX-3324 in healthy participants and patients with eosinophilic esophagitis (EoE).
NCT06443346
This is a prospective registry of all the Eosinophilic Esophagitis (EoE) patients referred to the third level referral centre of San Raffaele Scientific Institute
NCT07012928
Eosinophilic esophagitis (EoE) is an allergic inflammation of the esophagus. If not treated properly, inflammation and narrowing of the esophagus can occur. This can eventually lead to food impaction. Food allergens play an important role in the pathogenesis of EoE, as demonstrated by endoscopic and clinical resolution of EoE once the causative food is removed from the diet and exacerbation when the same food is reintroduced Similarly, amino acid-based elemental diets are effective in both adults and children with EoE. However, the exact mechanism by which food allergens can initiate inflammation in EoE is still unknown, as there are limited data on the early local esophageal immune response after challenge with a specific food trigger. Previous research has shown that this can be treated with antacids (PPI) and corticosteroids. This reduces the permeability of the esophagus (which is increased in EoE), but not to the level of healthy individuals. Most likely this is due to a mild underlying allergic inflammation that persists under treatment with the above agents. The idea is that dupilumab inhibits this type II inflammation, which will further reduce the permeability. In addition, the effect of food allergens on esophageal biopsies from both EoE patients and healthy patients will be examined. This will then be compared to the biopsies taken after the use of dupilumab.
NCT01988285
Purpose: To validate our previously developed model of risk factors for diagnosis of eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in diagnosis and monitoring of treatment of EoE. Participants: Up to a total of 800 participants (approximately 400 with EoE and 400 without EoE) who are referred for upper endoscopy. Procedures: This is a prospective cohort study. Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers. Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, possible saliva collection, possible urine collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers, including eotaxin-3 and IL-13.
NCT06389994
Patients with IgE mediated food Allergy have elevated risk of eosinophilic esophagitis, and new therapies like oral immunotherapy (OIT) carry additional risk of Eosinophilic Esophagitis (EoE). The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT therapy. Investigators will compare the efficacy of the Esophageal String Test to symptom assessment using a validated patient reported symptom questionnaire, the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. Investigators will utilize these tools to screen patients at their baseline visit prior to the start of OIT, then at the 3- and 6-month OIT follow-up visits.
NCT06756581
Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction. While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease. The most frequent dietary trigger for EoE is milk, but there is limited data on the effect of baked dairy . Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of baked dairy in patients with cow's milk triggered EoE. Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Some patients tolerate baked dairy products, which are less allergenic due to denaturation of proteins through heat. The potential for baked dairy to be included in the diet of milk-triggered EoE patients remains unexplored in current guidelines. The aim of this study is to assess tolerability and safety of baked dairy in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.
NCT04416217
This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.
NCT06705387
The goal of this clinical trial is to \[primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.\] in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. The main question\[s\] it aims to answer \[is/are\]: Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? Does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? Are comparative effective clinical trials feasible in this patient population? Researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response. Participants will be asked to: * Be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily. * Participate in 8 study visits over 52 weeks * Complete questionnaires * Have an endoscopy with biopsies and EndoFLIP measurements. * Swallow an Esophageal String Test
NCT04653324
The FARE Patient Registry will serve as a prospective, observational food allergy reporting system that stores detailed health and other basic information about patients' real-world experiences with food allergies, to encourage open sharing of de-identified data and participation in clinical trials. The FARE Patient Registry intends to make and support scientific discoveries by enabling the food allergy community to participate directly in research.
NCT03245840
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.