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Eosinophilic Esophagitis clinical trials

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NCT ID: NCT05755477 Recruiting - Clinical trials for Eosinophilic Esophagitis

Survey About the Relationship Beetween Allergic Rhinitis and Seasonal EOE Exacerbations

Start date: January 3, 2021
Phase:
Study type: Observational

Eosinophilic esophagitis (EoE) is a chronic inflammatory esophagus disease that is presented in patients with a history of recurrent dysphagia. EoE is closely related to other pathologies with an immuno-allergic etiopathogenesis such as atopic dermatitis (AD), IgE-mediated food allergy, allergic rhinitis and bronchial asthma. While the importance of the correlation between diet and food allergy has been largely demonstrated, less is known about the exact role of sensitization to aerollergens in the progression and recrudescence of symptoms. In support of this correlation there is evidence of a seasonal trend in the new diagnoses of EoE, of the possibility of the de-novo onset of the pathology following massive exposure to a specific aeroallergen and the demonstration that the degree of esophageal eosinophilia varies according to the climatic zone and the season of the year. The detailed knowledge of this correlation could clarify some aspects of the etiopathogenesis and natural history of EoE, improve and personalize the clinical-diagnostic management of affected patients and provide new therapeutic targets. Our aim is evaluating the possible existence of a correlation between the recrudescence of dysphagia symptoms and a specific month of the year and/or specific season.

NCT ID: NCT05730933 Recruiting - Clinical trials for Eosinophilic Esophagitis

An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

In many chronic conditions adherence to long-term treatment is a challenge, also for patients with eosinophilic esophagitis. Interventions, such as behavioral, educational and reminder interventions might improve treatment adherence. With this trial the investigators want to assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult patients with eosinophilic esophagitis.

NCT ID: NCT05695456 Recruiting - Clinical trials for Eosinophilic Esophagitis

Targeted Elimination Diet in EoE Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy

CLE-EoE
Start date: February 16, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Using confocal laser endomicroscopy (CLE), gastrointestinal allergic reactions to certain foods in the duodenum will be evaluated on a cellular level. After that, a personalized exclusion diet will be followed based on the CLE results for 6 weeks, sham-controlled, in a cross-over fashion. Gastroscopy with esophageal biopsies will be repeated after each diet.

NCT ID: NCT05622214 Recruiting - Clinical trials for Eosinophilic Esophagitis

The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active EoE

Start date: July 25, 2022
Phase: N/A
Study type: Interventional

Eosinophilic esophagitis (EoE) is a chronic, relapsing, immune-mediated esophageal disease. Clinical manifestations in infants and toddlers generally include vomiting, food refusal, choking with meals and, less commonly, failure to thrive. The management of the disease includes dietary and pharmaceutical interventions, and the goal of the treatment should ideally be both the resolution of symptoms and the normalization of the macroscopic and microscopic abnormalities. Milk is the most common food trigger identified, followed by wheat, soy, and eggs. The aim of the study is to examine the tolerability of a new plant based formula made of minimally processed almond and buckwheat and enriched with vitamins and minerals.

NCT ID: NCT05608681 Recruiting - Clinical trials for Eosinophilic Esophagitis

A Trial to Evaluate EP-104IAR in Adults With Eosinophilic Esophagitis (EoE).

RESOLVE
Start date: March 31, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

An open-label, dose-escalation study to explore the safety, tolerability and pharmacokinetics of EP-104IAR in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104IAR on eosinophilic EoE disease activity. The study will evaluate up to 8 doses of EP-104IAR (4 mg to 40 mg) in cohorts of 3 to 6 participants per cohort. If all planned cohorts are evaluated, or cohorts need to be repeated, up to 24 participants could be enrolled. The study involves 7 site visits spread over approximately 32 weeks. All participants will receive active study drug (EP-104IAR), The study drug will be administered by qualified personnel during an esophagogastroduodenoscopy (EGD) procedure at the Baseline/Dosing visit. Safety will be assessed throughout the study. Blood and urine samples will be collected at site visits for laboratory assessments and to measure plasma levels of EP-104IAR. Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3 EGDs with esophageal biopsies at the Baseline/Dosing Visit, and at 4 and 12 weeks post dose.

NCT ID: NCT05583227 Recruiting - Clinical trials for Eosinophilic Esophagitis

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

CROSSING
Start date: November 10, 2022
Phase: Phase 3
Study type: Interventional

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).

NCT ID: NCT05485155 Recruiting - Clinical trials for Eosinophilic Esophagitis

Zemaira Eosinophilic Esophagitis Pilot Study

ZEEPS
Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.

NCT ID: NCT05342168 Recruiting - Clinical trials for Eosinophilic Esophagitis

Comparison of Histology From a Mesh Sponge and Traditional Esophageal Biopsies in Children and Adolescents With EoE

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The aim of the present study is determining the accuracy, safety and tolerance of the CytospongeTM (expandable sponge within a gelatin capsule attached to a string) relative to traditional upper endoscopy and esophageal biopsies in older children and adolescents with a diagnosis of Eosinophilic Esophagitis (EoE) to follow up on treatment changes. The findings from this study could help determine whether the CytospongeTM is a more cost-effective alternative to traditional upper endoscopy for histologic follow-up in children and adolescents with EoE.

NCT ID: NCT05246085 Recruiting - Clinical trials for Eosinophilic Esophagitis

Evaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis on Chronic Swallowed Topical Steroids

Start date: August 10, 2022
Phase:
Study type: Observational

Eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, is a clinical and financial burden to patients if left untreated. Often the natural history of the disease includes development of fibrosis and stricturing of the esophagus, acute food impactions, unplanned emergency room visits, and invasive procedures such as endoscopy. Currently there are no Food and Drug Administration (FDA) approved medications for the treatment of EoE. As such, pharmacologic options approved for use in asthma are used for treatment of EoE and include proton pump inhibitors and swallowed topical steroids. These medications are prescribed chronically as EoE is considered a lifelong disease. Chronic administration of exogenous steroids, when given in inhaled or systemic preparations, can lead to adrenal insufficiency (AI). AI is seen in 7.8% of patients receiving chronic inhaled steroids and 48.7% of patients receiving chronic systemic steroids. The administration of steroids in EoE is unique, as patients typically swallow topical preparations of the drug. The risk of secondary AI from taking swallowed topical steroids is currently unknown, as there has been no study in an adult population assessing this risk as a primary endpoint. Pediatric studies of patients with EoE have shown the risk of AI from swallowed topical steroids to be 5-10%. Based on the risk of AI with inhaled steroids (7.8% prevalence) and the prevalence of AI from swallowed topical steroids in pediatric populations (5-10%), we hypothesize that the risk with swallowed topical steroids is >5%. This could warrant consideration of screening given the potentially serious consequences of undiagnosed AI. To address this hypothesis, this project aims to define the prevalence of developing AI in adults with EoE taking swallowed topical steroids and compare that prevalence to a similar control population of adults with EoE who are taking proton pump inhibitors.

NCT ID: NCT05229432 Recruiting - Gastroparesis Clinical Trials

Study of Gastric Motility in Eosinophilic Gastritis

OAT-FEED
Start date: January 25, 2023
Phase:
Study type: Observational

Purpose: The study is a cross-sectional observational study designed to determine if eosinophilic gastritis (EG) results in gastric motility impairment. Hypothesis: Gastric dysfunction occurs in the natural history of EG but is underdiagnosed due, in part, to contraindications to the use of the standard meals used in gastric emptying studies.