FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

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 eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected for microscopic analysis. Treatments are then decided based on how the tissue looks. 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 (≥15 eos/hpf for EoE, ≥30 eos/hpf for EG, ≥32 eos/hpf for EC) - Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed - EC patients must have a history of one of the following at the time of colonoscopy: 1.
anemia 2. peripheral eosinophilia 3. hemoccult positive stool 4. EGID 5. allergic disease (allergic rhinitis, asthma, food allergy, eczema or other allergic features suggestive of atopic disease)

Exclusion Criteria:

- History of intestinal surgery other than G tube placement - Enrolled in a blinded investigational study - 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.

OtherNIHNIHNIHNIH
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 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, 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.

University of Utah, Salt Lake City, Utah

Status

Not yet recruiting

Address

University of Utah

Salt Lake City, Utah, 84112

Site Contact

Jennifer Knowles

Jennifer.Knowles@hsc.utah.edu

801-587-9050

Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine & Texas Children's Hospital

Houston, Texas, 77030

Site Contact

Munazza Noor

munazza.noor@bcm.edu

832-824-0939

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Maureen Demarshall

demarshm@mail.med.upenn.edu

215-349-8546

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Leah Wilkey

wilkeyl@email.chop.edu

215-590-2549

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Heidi Poppendeck, MPH

heidi.poppendeck@cchmc.org

513-803-3078

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Shiyan Shoyoye

shoyoye@med.unc.edu

919-843-0688

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

Gabriela Mendoza

gabriela.mendoza@mssm.edu

212-241-8780

Tufts University, Boston, Massachusetts

Status

Recruiting

Address

Tufts University

Boston, Massachusetts, 02111

Site Contact

Teresa Brown

Tbrown6@tuftsmedicalcenter.org

617-636-4941

National Institutes of Health (NIH), Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health (NIH)

Bethesda, Maryland, 20892

Site Contact

Nicole Holland-Thomas

nicole.holland2@nih.gov

301-402-5969

University of Illinois at Peoria, Peoria, Illinois

Status

Recruiting

Address

University of Illinois at Peoria

Peoria, Illinois, 61637

Chicago, Illinois

Status

Recruiting

Address

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

Chicago, Illinois, 60611

Site Contact

Katie Keeley

kkeeley@luriechildrens.org

312-227-4546

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60208

Site Contact

Angelika Zalewski

angelika.zalewski@northwestern.edu

312-695-4036

Children's Hospital Colorado, Denver, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Denver, Colorado, 80218

University of Colorado Denver, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Denver

Aurora, Colorado, 80045

Site Contact

Jonathan Cahoon

jonathan.cahoon@ucdenver.edu

303-724-8974

University of California, San Diego, La Jolla, California

Status

Recruiting

Address

University of California, San Diego

La Jolla, California, 92093

Site Contact

Lea Jacinto

Ljacinto@ucsd.edu

858-657-5131

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.