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Eosinophilic Esophagitis clinical trials

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NCT ID: NCT04149470 Recruiting - Clinical trials for Eosinophilic Esophagitis

Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)

Start date: October 7, 2020
Phase: Phase 4
Study type: Interventional

This study will enroll participants who have been diagnosed with Eosinophilic Esophagitis (EoE). Upon study enrollment, the participant will begin a proton pump inhibitor (PPI), Omeprazole 20mg twice daily. After taking Omeprazole for four weeks, the participant will have a Transnasal Endoscopy, and biopsies will be taken to determine the histological change. If the biopsies are abnormal, the participant continues Omeprazole and will undergo another endoscopy at eight weeks. The study aims to determine the percentage of children with Eosinophilic Esophagitis who improve with PPI use and to determine the length of time and effectiveness of PPI therapy in the management of EoE. The investigators hypothesize that following the initiation of PPI for treatment of Eosinophilic Esophagitis, biopsies obtained will show decreasing eosinophil counts at four weeks, which is sooner than the previously reported eight-week period.

NCT ID: NCT03980886 Recruiting - Clinical trials for Eosinophilic Esophagitis

Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)

EoE
Start date: February 11, 2019
Phase:
Study type: Observational

Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers

NCT ID: NCT03858426 Recruiting - Clinical trials for Eosinophilic Esophagitis

Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

RENESE
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

1. Registry of demographic, clinical, endoscopic and histological data at baseline. 2. Registry of patients treated with PPI: - Clinical, endoscopic and histological response at 8-12 weeks of induction treatment - Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment 3. Registry of patients treated with two foods elimination diet: - Clinical, endoscopic and histological response at 8-12 weeks of induction treatment - Identification of food trigger: milk, gluten or milk and gluten - Clinical, endoscopic and histological response at one year elimination of food trigger - Registry of adverse events 4. Registry of patients treated with swallowed steroids (budesonide or fluticasone): - Clinical, endoscopic and histological response at 8-12 weeks of induction treatment - Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment - Registry of adverse events

NCT ID: NCT03781596 Recruiting - Clinical trials for Eosinophilic Esophagitis

EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

Start date: October 2, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of combination therapy with omeprazole and swallowed fluticasone vs fluticasone therapy and placebo in the treatment of Eosinophilic Esophagitis (EoE) in children and adults. This study will be a double-blinded, randomized controlled trial. The primary outcome measured will be histologic assessment of esophageal tissue biopsies measuring number of eosinophils per high power field (eos/hpf). Secondary outcomes will be endoscopic findings and symptomatic changes following therapy using validated endoscopic scoring measures and participant surveys, respectively.

NCT ID: NCT03615950 Recruiting - Clinical trials for Eosinophilic Esophagitis

Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis

Start date: October 1, 2019
Phase:
Study type: Observational

Eosinophilic esophagitis (EoE) is characterized by allergy-driven inflammation of the esophagus leading to a variety of gastrointestinal symptoms and increased healthcare utilization. While considered a rare disease, EoE is rapidly increasing in prevalence in the United States. Treatment options are limited and include dietary modifications with the elimination of suspected food triggers or pharmacological options including proton pump inhibitors (PPIs) and swallowed corticosteroids. Compliance to strict elimination diets is difficult thus many patients elect to use swallowed corticosteroids. Because nearly half of all EoE patients are treated with swallowed corticosteroids there is a growing concern regarding the long-term effects of this class of medication.4 It is known that oral corticosteroids can compromise bone mineral density and growth velocity5-7. Furthermore, there have been multiple studies exploring the relationship between inhaled corticosteroids (ICS) and endocrine effects in asthmatics. While the risk of ICS use is less compared to systemic corticosteroids, higher ICS doses do cause deleterious effects on growth and bone health8-11. Currently, there are no published studies examining the effect of swallowed corticosteroids on bone mineral density or growth velocity in patients with EoE. Given the route of administration, there may be more systemic absorption leading to a higher risk of long-term complications. The proposed work will address the following specific aims: Specific Aim 1: Assess effects of swallowed corticosteroids on bone mineral density (primary outcome) in children 5-12 years of age with EoE compared to age matched controls. Specific Aim 2: Evaluation of the effect of swallowed corticosteroids on growth velocity.

NCT ID: NCT03312686 Recruiting - Clinical trials for Eosinophilic Esophagitis

Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study

EOE
Start date: November 2016
Phase:
Study type: Observational

This pilot study will explore whether treatment of eosinophilic inflammation in the esophagus is associated with an improved distensibility of the esophagus. Furthermore, previous studies of the esophagus using EndoFlip only measured distensibility of the distal esophagus, specifically the distal esophagus and esophagogastric junction. Eosinophilia in EoE has been demonstrated to affect both upper, middle and lower esophagus. The aim is to measure distensibility both proximal and distal, before and after treatment.

NCT ID: NCT02873468 Recruiting - Clinical trials for Eosinophilic Esophagitis

Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis

Start date: April 19, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of three doses of Florence oral suspension on changes of eosinophilic infiltration in esophageal biopsies.

NCT ID: NCT02523118 Recruiting - Clinical trials for Eosinophilic Esophagitis

OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

OMEGA
Start date: July 17, 2015
Phase:
Study type: Observational

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 EoE, EG, EGE and EC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. 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 is doing.

NCT ID: NCT02504853 Recruiting - Atopic Dermatitis Clinical Trials

Natural History and Genetics of Food Allergy and Related Conditions

Start date: July 29, 2015
Phase:
Study type: Observational

Background: - About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them. Objective: - To learn more about the causes and effects of food allergy and related conditions. Eligibility: - People ages 2 99 who have food allergy and/or a related genetic or other condition - Their relatives - Healthy relatives and volunteers Design: - Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer. - Participants will be screened with medical history, physical exam, and questionnaires. - Participants may have the following: - Blood tests - Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop. - Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm. - X-rays - Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour. - EGD and colonoscopy: Biopsies are taken from the gastrointestinal system. - Tiny biopsies of skin - Photographs of the body - Collection of cells through: - Swab of nose, inside of cheek, or skin - Gentle skin scrape - Tape stripping: piece of tape is put on the skin and pulled off.

NCT ID: NCT02453126 Recruiting - Clinical trials for Eosinophilic Esophagitis

Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

Start date: December 2014
Phase:
Study type: Observational

This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis (EoE) is characterized by abnormal esophageal structure and compliance compared to non fibrostenotic EoE and that distinctive cellular and molecular profiles predict the fibrostenotic phenotype. This study aims to define and assess the changes that occur in the structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along with characterizing the histologic and molecular patterns in fibrostenotic EoE.