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OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 3 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02523118
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital Medical Center, Cincinnati
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marc E Rothenberg, MD, PhD
Principal Investigator Affiliation Children's Hospital Medical Center, Cincinnati
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Colitis
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Research Institute, Rogers, Arkansas

Status

Recruiting

Address

Arkansas Children's Research Institute

Rogers, Arkansas, 72758

Site Contact

Lori Lednick-Hayes

[email protected]

501-364-3755

Rady Children's Hospital, San Diego, California

Status

Recruiting

Address

Rady Children's Hospital

San Diego, California, 92123

Site Contact

Kira Chaiboonma

[email protected]

858-966-1700 #226884

University of Colorado Denver, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Denver

Aurora, Colorado, 80045

Site Contact

Jonathan Cahoon

[email protected]

303-724-8974

Children's Hospital Colorado, Denver, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Denver, Colorado, 80218

Site Contact

Cassandra Burger

[email protected]

720-777-5739

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60208

Site Contact

Tenesha Thomas

[email protected]

513-636-4821

Chicago, Illinois

Status

Recruiting

Address

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

Site Contact

Katie Keeley

[email protected]

312-227-4546

Riley Children's Hospital, Indianapolis, Indiana

Status

Recruiting

Address

Riley Children's Hospital

Indianapolis, Indiana, 46202

Site Contact

Gail Waltz

[email protected]

513-636-4821

National Institutes of Health (NIH), Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health (NIH)

Bethesda, Maryland, 20892

Site Contact

Perla Adames-Castillo

[email protected]

513-636-4821

Tufts University, Boston, Massachusetts

Status

Completed

Address

Tufts University

Boston, Massachusetts, 02111

Mayo Clinic, Rochester, Minnesota

Status

Completed

Address

Mayo Clinic

Rochester, Minnesota, 55902

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Grant Eickel

[email protected]

212-241-4908

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Sean Lafata

[email protected]

919-966-1757

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Lauren Turner, MS

[email protected]

513-636-4200

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Michael Pratt

[email protected]

215-590-2549

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Lilly Hennessey

[email protected]

215-349-8222

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Regina Tyree

[email protected]

615-343-6845

Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine & Texas Children's Hospital

Houston, Texas, 77030

Site Contact

Amanda Vega

[email protected]

832-824-0939

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84112

Site Contact

Brinnlie Harward

[email protected]

801-585-0894

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