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NCT02523118 Clinical Trial

OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Eosinophilic Esophagitis Clinical Trial

— OMEGA  

Official title:
A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients With Eosinophilic Esophagitis (EoE), Gastritis (EG), Gastroenteritis (EGE) and Colitis (EC)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02523118
Other study ID # 2015-2311
Secondary ID U54AI117870
Status Recruiting
Phase
First received
Last updated
Start date July 17, 2015
Est. completion date January 1, 2051

Study information
Verified date December 2022
Source Children's Hospital Medical Center, Cincinnati
Contact Kara Kliewer, PhD
Phone 513-636-4821
Email Kara.kliewer@cchmc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EG, EGE and EC will be followed over the course of time to see if standard questionnaires can give us an idea of how well the person is doing. Participants undergoing standard of care (normal, routine care) endoscopies and/or colonoscopies will have biopsies (small pieces of tissue from the GI tract normally collected during these procedures) collected and used for the research study. Participants will also complete questionnaires related to their symptoms and quality of life. Participants will be followed over the course of time and asked to complete the questionnaires at various time points throughout the study.

Recruitment information / eligibility
Status Recruiting
Enrollment 1350
Est. completion date January 1, 2051
Est. primary completion date December 1, 2050
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility Inclusion Criteria: - Males or females 3 years of age and older - Mucosal eosinophilia: EoE = 15 eosinophils/HPF in the distal or proximal esophagus, EG = 30 eosinophils/HPF in 5 HPF's in the body and/or antrum, EGE = 53 eosinophils/HPF in the duodenum and/or = 56 eosinophils/HPF in the jejunum and/or ileum, EC = 84 eosinophils/HPF from the transverse or descending colon and/or = 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with = 100 eosinophils/HPF - Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed. Exclusion Criteria: - History of intestinal surgery other than G tube placement - Enrolled in a blinded investigational study at the time of the first study visit - Have esophageal stricture (<3mm) - Have other identifiable causes for eosinophilia (except Inflammatory Bowel Disease): infections, Gastrointestinal (GI) cancer, other GI inflammatory disease (e.g., Ulcerative Colitis or Crohn's Disease)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Colorado Denver Aurora Colorado
United States National Institutes of Health (NIH) Bethesda Maryland
United States Tufts University Boston Massachusetts
United States University of North Carolina, Chapel Hill Chapel Hill North Carolina
United States Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Northwestern University Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Children's Hospital Colorado Denver Colorado
United States Baylor College of Medicine & Texas Children's Hospital Houston Texas
United States Riley Children's Hospital Indianapolis Indiana
United States Vanderbilt University Medical Center Nashville Tennessee
United States Icahn School of Medicine at Mount Sinai New York New York
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Arkansas Children's Research Institute Rogers Arkansas
United States University of Utah Salt Lake City Utah
United States Rady Children's Hospital San Diego California

Sponsors (5)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati National Center for Advancing Translational Sciences (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), ORDR

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mucosal eosinophilia (eos/hpf) Mucosal eosinophil levels are measured as eosinophils per high power field (eos/hpf). The primary outcome measure is to determine the change in mucosal eosinophil level (eos/hpf) and to determine if the change in mucosal eosinophil level in eos/hpf correlates with the change in scores on clinical outcome measure metrics. Duration of funding, at least 10 years
See also
  Status Clinical Trial Phase
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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
Recruiting NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
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 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
Completed NCT00961233 - Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE) N/A

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