Eosinophilic Gastrointestinal Disorders (EGIDs)OMEGANCT02523118
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
An observational study of Eosinophilic Gastrointestinal Disorders (EGIDs) and Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 19 sites in United States.
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, EoG, EoN and EoC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis, Eosinophilic Gastritis
- How many people
- 1,350 participants
- Where
- 19 sitesUnited States
- Study dates
- 17 Jul 2015to 1 Jan 2051
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males and females ages 3 or greater with EoE, EoG, EoN or EoC.
Who may be able to join
- Males or females 3 years of age and older
- Mucosal eosinophilia:
- EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus EoG ≥ 30 eosinophils/HPF in 5 HPF\'s in the body and/or antrum EoN ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum EoC ≥ 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.
Who cannot join
- 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 locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 16 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Keanna Capener, 303-724-8974, keanna.capener@cuanschutz.edu
Paul Menard-Katcher, MD
- Recruiting
National Institutes of Health (NIH)
Bethesda, Maryland, 20892
Perla Adames-Castillo, perla.adamescastillo@nih.gov
Paneez Khoury, MD
- Completed
Tufts University
Boston, Massachusetts, 02111
- Recruiting
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Lucas Plott, 919-966-8559, lucas_plott@med.unc.edu
Evan Dellon, M.D., MPH
- Recruiting
Northwestern University
Chicago, Illinois, 60208
Tenesha Thomas, tenesha.thomas@northwestern.edu
Ikuo Hirano, M.D.
- Recruiting
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Mary Riordan, 312-227-4558, mriordan@luriechildrens.org
Joshua Wechsler, M.D.
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Bliss Magella, 513-636-7832, bliss.magella@cchmc.org
Marc E. Rothenberg, MD, PhD
- Recruiting
Children's Hospital Colorado
Denver, Colorado, 80218
Rachel Andrews, (720) 777-1994, rachel.andrews@childrenscolorado.org
Glenn Furuta, M.D.
- Recruiting
Baylor College of Medicine & Texas Children's Hospital
Houston, Texas, 77030
Amanda Vega, 832-824-0939, amandav@bcm.edu
Daisy Vita (Tran), (832)-824-3640, dxtran1@texaschildrens.org
- Completed
Riley Children's Hospital
Indianapolis, Indiana, 46202
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Regina Tyree, (615) 343-6845, regina.n.tyree@vumc.org
Girish Hiremath, MD, MPH
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Jaimie Gowatsky, 212-241-4908, jaimie.gowatsky@mssm.edu
Mirna Chehade, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Ignacio De La Torre, 215-590-6187, delatorrei@chop.edu
Jonathan Spergel, MD, PhD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Erin Lee, 215-662-2493, Erin.Lee1@pennmedicine.upenn.edu
Maureen DeMarshall, 215-349-8546, demarshm@mail.med.upenn.edu
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Renee Nunez, 480-301-4992, nunez.renee@mayo.edu
Benjamin Wright, M.D.
- Completed
Mayo Clinic
Rochester, Minnesota, 55902
- Recruiting
Arkansas Children's Research Institute
Rogers, Arkansas, 72758
Allison Bruton, 501-364-1060, CongletonAL@archildrens.org
Robert Pesek, MD
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Sophia Schuman, 801-585-0894, sophia.schuman@hsc.utah.edu
Kathryn Peterson, MD
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Kira Chaiboonma, (858)-966-1700 ext. 226884, kchaiboonma@health.ucsd.edu
Seema Aceves, M.D., PhD
About this study
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 (EoG), Enteritis (EoN) and Colitis (EoC)
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, EoG, EoN and EoC 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.
Read the detailed description
This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EoG, EoN and EoC 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.
- Conditions
- Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Colitis
- Medical subject headings
- Eosinophilic Esophagitis, Eosinophilic enteropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of funding, at least 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start17 Jul 2015
- Primary completion1 Dec 2050 (estimated)
- Study completion1 Jan 2051 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic Gastrointestinal Disorders (EGIDs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), ORDR, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Marc E Rothenberg, MD, PhD, Principal investigator, Cincinnati Children's Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523118
- Sponsor's protocol ID
- 2015-2311
- Other IDs
- U54AI117870
- Acronym
- OMEGA
- Status last verified
- Aug 2025
- First submitted
- 22 Jun 2015
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Safroneeva E, Pan Z, King E, Martin LJ, Collins MH, Yang GY, Capocelli KE, Arva NC, Abonia JP, Atkins D, Bonis PA, Dellon ES, Falk GW, Gonsalves N, Gupta SK, Hirano I, Leung J, Menard-Katcher PA, Mukkada VA, Schoepfer AM, Spergel JM, Wershil BK, Rothenberg ME, Aceves SS, Furuta GT; Consortium of Eosinophilic Gastrointestinal Disease Researchers. Long-Lasting Dissociation of Esophageal Eosinophilia and Symptoms After Dilation in Adults With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2022 Apr;20(4):766-775.e4. doi: 10.1016/j.cgh.2021.05.049. Epub 2021 May 29.
PubMed 34062314
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 (EoG), Enteritis (EoN) and Colitis (EoC)
- ClinicalTrials.gov ID
- NCT02523118
- Acronym / sponsor ID
- OMEGA / 2015-2311
- Conditions
- Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Colitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), ORDR, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Jul 2015 (actual)
- Primary completion
- 1 Dec 2050 (estimated)
- Study completion
- 1 Jan 2051 (estimated)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, EoG, EoN and EoC 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.
Detailed description
This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EoG, EoN and EoC 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males and females ages 3 or greater with EoE, EoG, EoN or EoC.
Key inclusion criteria (4 listed)
- Males or females 3 years of age and older
- Mucosal eosinophilia:
- EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus EoG ≥ 30 eosinophils/HPF in 5 HPF\'s in the body and/or antrum EoN ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum EoC ≥ 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mucosal eosinophilia (eos/hpf)
Time frame: Duration of funding, at least 10 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 34062314Safroneeva E, Pan Z, King E, Martin LJ, Collins MH, Yang GY, Capocelli KE, Arva NC, Abonia JP, Atkins D, Bonis PA, Dellon ES, Falk GW, Gonsalves N, Gupta SK, Hirano I, Leung J, Menard-Katcher PA, Mukkada VA, Schoepfer AM, Spergel JM, Wershil BK, Rothenberg ME, Aceves SS, Furuta GT; Consortium of Eosinophilic Gastrointestinal Disease Researchers. Long-Lasting Dissociation of Esophageal Eosinophilia and Symptoms After Dilation in Adults With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2022 Apr;20(4):766-775.e4. doi: 10.1016/j.cgh.2021.05.049. Epub 2021 May 29.
- Learn more about CEGIR at this website.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc E Rothenberg, MD, PhD principal investigator
Cincinnati Children's Hospital Medical Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Gastrointestinal Disorders (EGIDs) and Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bliss Magella (513-636-7832, bliss.magella@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal eosinophilia (eos/hpf) (time frame: Duration of funding, at least 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02523118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.