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Esophagitis clinical trials

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NCT ID: NCT05192538 Recruiting - GERD Clinical Trials

A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

Start date: February 10, 2022
Phase: N/A
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment. In the study, the investigators used the novel pre-test to narrow the gastric cardia to control symptoms temporarily to decide whether to undergo irreversible surgery or endoscopic treatment.Thirty patients were enrolled and underwent endoscopic endoloop pre-test treatment. The Primary outcome in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. The secondary outcomes included improvement in esophageal 24-hr pH monitoring, improvement in quality of life questionnaires and safety. Patient follow-up assessments were completed at 7 and 14 days post treatment.

NCT ID: NCT05180578 Recruiting - Clinical trials for Eosinophilic Esophagitis

Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger

Start date: November 12, 2020
Phase: N/A
Study type: Interventional

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 cross-reactivity of milk from other species. Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of non-bovine milk in patients with cow's milk triggered EoE. Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Our own, anecdotal experience in two patients with milk triggered EoE who requested to introduce goat's milk into the patients' diet were that reintroduction did not trigger a clinical or histological flare of EoE. These cases of successful introduction of non-bovine milk introduces the possibility that a milk-free diet need not necessarily be exclusive of all species. The aim of this study is to assess tolerability and safety of goat's milk in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.

NCT ID: NCT05176262 Active, not recruiting - Clinical trials for Eosinophilic Esophagitis

A Prospective Study of the Four Food Elimination Diet for Treatment of Eosinophilic Esophagitis

Start date: July 2011
Phase:
Study type: Observational [Patient Registry]

This study is to observe the efficacy of the four food elimination diet.

NCT ID: NCT05176249 Active, not recruiting - Clinical trials for Eosinophilic Esophagitis

Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population

EoE
Start date: October 2011
Phase:
Study type: Observational [Patient Registry]

Eosinophilic Esophagitis (EoE) is a chronic, immune-mediated allergic inflammatory disorder that is being diagnosed with increased frequency. Compelling evidence suggests the etiopathogenesis is allergic and the immune response is triggered by food antigens in most children afflicted with this condition. The literature characterization of EoE is descriptive and retrospective thus far. Our aim in collecting and analyzing data prospectively of all EoE patients seen at Ann & Robert H. Lurie Children's Hospital (Lurie Children's) is to better understand the etiology, pathogenesis and clinical presentation of EoE in patients to better delineate its association with other atopic conditions including reactive airway disease, seasonal allergies and atopic dermatitis. This will allow us to better evaluate the effectiveness of therapeutic strategies used to treat patients with EoE. In addition to collecting data prospectively, the investigators will also review the charts of EoE patients and those suspected of having EoE seen at Lurie Children's. This will allow us to also gather information on control patients, not diagnosed with EoE, who may not be followed in EoE clinic.

NCT ID: NCT05175352 Recruiting - Clinical trials for Eosinophilic Esophagitis

A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab

Start date: June 7, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study to evaluate the potential for disease-mediated drug-drug interactions between cendakimab and selected substrates of metabolic enzymes in eosinophilic esophagitis participants.

NCT ID: NCT05129670 Completed - Esophagitis Clinical Trials

Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum

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

This investigation is designed to evaluate the acid neutralisation action of a new test product versus unmatched placebo.

NCT ID: NCT05109819 Recruiting - Radiation Toxicity Clinical Trials

Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

ESO-SPARE
Start date: May 20, 2021
Phase: N/A
Study type: Interventional

Metastatic spinal cord compression (MSCC) is a serious complication to metastatic cancer and when diagnosed life expectancy is short. Treatment is palliative radiotherapy (RT). Early esophageal toxicity is underreported but can seriously impact quality of life (QoL). The aim of the ESO-SPARE trial is to investigate if esophagus sparing RT can decrease patient reported esophageal toxicity without compromising ambulatory function or increase other toxicities. 200 patients with MSCC in the thoracic or cervical spine referred for RT will be randomized to either standard or esophagus/pharynx sparing RT. Subsequently participants will be followed with PROM (Patient Reported Outcome Measures) for 9 weeks. PROM-CTCAE questionnaires on upper GI toxicity and pain will be collected daily for 5 weeks and weekly for 4 weeks. Questionnaires evaluating QoL and physical function will be collected weekly for 9 weeks.

NCT ID: NCT05095116 Available - Clinical trials for Eosinophilic Esophagitis

Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Start date: n/a
Phase:
Study type: Expanded Access

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.

NCT ID: NCT05084963 Completed - Clinical trials for Eosinophilic Esophagitis

A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis

Start date: October 29, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to asses the efficacy, safety and tolerability of repeat doses of IRL201104 in Adult Participants with Active Eosinophilic Esophagitis (EoE)

NCT ID: NCT05083312 Completed - Clinical trials for Eosinophilic Esophagitis

Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial

FLUTEEN
Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an open-label extension (OLE) in adolescents (≥12 to <18 years) with EoE.