Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Status Terminated

Clinical Trial Summary

Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to swallow, and this leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and poor growth or weight loss in children The main purpose of this research study is to compare the effectiveness of two different types of treatment for EoE: 1. Oral viscous budesonide- which is a steroid medication that has been used to treat asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation in EoE, and 2. Specific food elimination. The study will also be looking to see if a blood test is useful in following the progression of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more "invasive test."

Clinical Trial Description

This study is a open label, randomized, prospective clinical trial comparing the efficacy of a topical steroid preparation to an antigen (food) elimination diet. A total of 40 participants will be recruited for this study that are positive for food allergens. Study participants will be randomly assigned to treatments as described below, and the duration of each treatment phase will be 16 weeks. The subjects will be randomized to group A and B. Subject and study team will NOT be blinded to the group assignments. Group A will receive oral viscous budesonide at a dose of 1 or 2 mg daily depending on the height. Group B will receive an elimination diet (elimination of the foods the subject is allergic to). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01821898
Study type	Interventional
Source	Baylor College of Medicine
Contact
Status	Terminated
Phase	Phase 2
Start date	July 9, 2013
Completion date	September 24, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03382678` - CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
Completed	`NCT05083312` - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial	Phase 3
Completed	`NCT04593251` - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis	Phase 1
Completed	`NCT03633617` - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)	Phase 3
Terminated	`NCT04543409` - A Study of Benralizumab in Patients With Eosinophilic Esophagitis	Phase 3
Completed	`NCT04941742` - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated	`NCT02314455` - Esophageal Absorption in EoE	N/A
Completed	`NCT01953575` - Mucosal Impedance and Eosinophilic Esophagitis	N/A
Completed	`NCT01386112` - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis	Phase 1/Phase 2
Recruiting	`NCT04991935` - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis	Phase 3
Not yet recruiting	`NCT05896891` - San Raffaele EoE Biobank
Active, not recruiting	`NCT05482256` - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis	N/A
Recruiting	`NCT05485155` - Zemaira Eosinophilic Esophagitis Pilot Study	Phase 2
Recruiting	`NCT04149470` - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)	Phase 4
Recruiting	`NCT04416217` - Eosinophilic Esophagitis Steroid Safety Study
Completed	`NCT05084963` - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis	Phase 2
Completed	`NCT02579876` - Milk Patch for Eosinophilic Esophagitis	Phase 2
Recruiting	`NCT02331849` - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.	N/A
Active, not recruiting	`NCT02202590` - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus	N/A
Active, not recruiting	`NCT05176249` - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population