View clinical trials related to Eosinophilic Esophagitis.
Filter by:This is a prospective registry of all the Eosinophilic Esophagitis (EoE) patients referred to the third level referral centre of San Raffaele Scientific Institute
Eosinophilic esophagitis is a recent and emerging chronic disease, secondary to eosinophilic infiltration of the esophageal mucosa leading to esophageal dysfunction. The diagnosis of this pathology, and monitoring of the efficacy of therapies, relies on the assessment of eosinophilic density on esophageal biopsies: follow-up requires numerous digestive endoscopies under general anesthesia, at each therapeutic change, to assess remission. The search for non-invasive biomarkers of active eosinophilic esophagitis is therefore a subject of major interest. The first step is to study EDN (Eosinophil-Derived Neurotoxin), a protein secreted when eosinophils are activated. Several studies have investigated the association between serum EDN, EDN on esophageal brushing or esophageal biopsies with eosinophilic esophagitis activity, and the results look promising. Urinary EDN is associated with atopy but has not been studied in eosinophilic esophagitis. EDN is a biomarker of interest because it is stable over time and, above all, can be measured routinely, making it applicable to routine patient management and care. Our main objective is to evaluate the correlation of EDN in urine, blood and esophageal brushings with the eosinophilic infiltrate counted on esophageal biopsies in patients undergoing upper GI endoscopy at Trousseau Hospital for suspected eosinophilic esophagitis, or as part of the re-evaluation of known eosinophilic esophagitis under treatment. Finally, esophageal and salivary dysbiosis has been described in eosinophilic esophagitis without direct evidence of its influence on esophageal inflammation and disease. Our secondary objective is to study the esophageal, salivary and fecal microbiota in these same patients in order to describe the composition, alpha and beta-diversity of bacterial and mycological flora between patients and controls, as well as their association with pathology, and to propose possible alternative therapies aimed at modulating the esophageal and/or salivary microbiota in the management of eosinophilic esophagitis. This study will be carried out on a cohort of pediatric patients followed up in the pediatric nutrition and gastroenterology department of the Trousseau-APHP hospital and hospitalized for upper GI endoscopy, either as part of a suspected case of eosinophilic esophagitis, or during follow-up of a previously known case of eosinophilic esophagitis. Blood, urine, stool, saliva, 4 additional esophageal biopsies and esophageal brushings were collected on the day of the digestive endoscopy. Depending on the eosinophilic densitý on the biopsies, subjects will be classified into either the "patient with active eosinophilic esophagitis" group, the "patient with eosinophilic esophagitis in remission" group, or the "control without eosinophilic esophagitis" group. The investigator aim to include 60 patients undergoing upper GI endoscopy, at least half of whoḿ will have active or remitting eosinophilic esophagitis. Furthermore, the study of the immunological, allergological and metabolomic signature of this disease is essential to enable the identification of new biomarkers to guide the creation of models combining several biomarkers predictive of eosinophilic density on esophageal biopsies. In a second step, the concentration of a panel of cytokines in blood and esophageal biopsies, the allergic sensitization profile in blood and esophageal biopsies, and an untargeted description of esophageal metabolomics will be compared between groups. In terms of clinical prospects, the investigator plan to develop a patient follow-up strategy based on the biomarkers studied, which is better adapted to clinical practice, better tolerated by patients and less costly than repeated endoscopies with esophageal biopsies.
The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab. Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses. Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed. At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test.
The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months. This study would also enable us to investigate the quality of life of these chronically ill patients
This is a retrospective monocentric observational study involving patients with Eosinophilic esophagitis (EoE), gastroesophageal reflux disease (GERD), and controls (patients without EoE and GERD). To validate the EoE-related markers obtained with the EoE TaMMA web app (such as CCL26, TBX5, NOX4, FGF7, CXCL14, ADAMTS5, PDGFRA, CXCL12, ACVRL1, POSTN, and LTBP4), we will stain and analyze EoE, GERD, and controls Formalin-fixed paraffin-embedded (FFPE) tissue samples already stored in the pathological laboratory of OSR. For this reason, this project will be accomplished thanks to the collaboration with prof. Doglioni's team at OSR.
Eosinophilic Esophagitis (EoE) is a immuno-mediated disease, characterised by a Th-2 food-antigen driven chronic inflammatory response of the esophagus. Main symptoms are dysphagia and food bolus impaction, frequently overlapping with most atypical and general symptoms like heartburn or regurgitation and difficulty to thrive in children. Overall incidence and prevalence of EoE are rapidly increasing. The complete comprehension of pathogenetic and molecular mechanism underlying this complex and relatively new disease is still to be conquered. For this reason, we created this EoE Biobank, in order to collect blood, oral and esophageal tissue samples of proven EoE patients to further exploit new insights of this disease.
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated, esophageal-restricted disease characterized clinically by symptoms related to esophageal dysfunction and histologically by an eosinophil-predominant inflammation.A dramatic increase in incidence and prevalence of EoE has been documented over the last 2 decades, especially in Western countries.EoE is currently the most common cause of dysphagia and bolus impaction, and the second leading cause of chronic esophagitis after gastroesophageal reflux disease.Predominant symptoms of EoE in adult patients are chronic dysphagia, food impaction, and chest pain.EoE is a chronic-progressive disease and, if left untreated, is usually associated with persistence of symptoms and inflammation.Furthermore, it is well established that the ongoing eosinophilic inflammation leads to esophageal remodeling, resulting in fibrosis with possible stricture formation and functional damage.Consequently, EoE has a substantial negative impact on the health-related quality of life (HRQoL) of patients and their families by causing emotional distress and restricting social activities.There is, therefore, a clear indication to treat patients suffering from active EoE. Today, swallowed topical-acting corticosteroids (STCs) are an established first-line pharmacologic treatment for patients with EoE.Proton pump inhibitors (PPIs) and dietary modifications are alternatives. From the first positive attempt to treat EoE with STCs, drugs that were originally developed for airway administration in patients with asthma and used off-label in eosinophilic esophagitis,multiple trials have confirmed the efficacy of these compounds in improving symptoms as well as inflammation in patients with EoE. Fluticasone or budesonide have shown comparable potencies, but the vehicle depositing the compound on the esophageal surface seems to be critical.Until now there has been no licensed therapy for eosinophilic esophagitis treatment; treatment using drugs adapted from other conditions has been limited and not standardized. Recently a new budesonide orodispersible tablet formulation (BOT, originally defined as an "effervescent tablet for orodispersible use [BET]") has been created and has been shown in clinical trials to be able to resolve both the symptoms and the underlying inflammation in EoE in most patients. Budesonide orodispersible tablet treatment has been shown to be significantly more effective than placebo in inducing clinical and histologic remission in patients affected by EoE. A phase 3 trial showed the effectiveness of a 6-week treatment with new budesonide orodispersible tablet (BOT) to induce clinicohistologic remission in 58% of adult patients with EoE, which increased to 85% when therapy was extended to 12 weeks in nonresponders. Another clinical trial showed that after 48 weeks of treatment, 73.5% of patients treated with low-dose and 75% of patients treated with high dose budesonide remained in remission, compared with 4.4% of patients treated with placebo. The budesonide orodispersible tablet formulation, with the name of Jorveza, received the marketing authorization valid in the EU on 8 January 2018 and recently received AIFA approval to be distributed in Italy as the first medicine with indication for eosinophilic esophagitis. Therefore, patients with eosinophilic esophagitis who are taking off-label corticosteroid formulations (fluticasone diproprionate and budesonide in galenic formulation) will need to make a therapeutic transition to Jorveza. No data are currently available in the literature about efficacy, safety and patient' satisfaction after therapeutic switch from off-label swallowed topical-acting corticosteroids to budesonide orodispersible tablet formulation (Jorveza).
A phase I/II, multicenter, double-blind, parallel, randomized trial to assess pharmacokinetics, efficacy, tolerability and safety of different budesonide oral gel doses in adults subjects of both genders with eosinophilic esophagitis (EoE)
In this study, we plan to investigate the accuracy of the EG-760Z endoscope (135x zoom) compared with standard imaging with histology as gold standard in detecting and grading inflammatory activity in patients with eosinophilic esophagitis (EoE).
The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.