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OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02523118
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : February 1, 2023
Sponsor:
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)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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Brief 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.

Condition or disease
Eosinophilic Gastrointestinal Disorders (EGIDs) Eosinophilic Esophagitis Eosinophilic Gastritis Eosinophilic Gastroenteritis Eosinophilic Colitis

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1050 participants
Observational Model: Case-Only
Time Perspective: Other
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)
Actual Study Start Date : July 17, 2015
Estimated Primary Completion Date : December 1, 2050
Estimated Study Completion Date : January 1, 2051

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Mucosal eosinophilia (eos/hpf) [ Time Frame: Duration of funding, approximately 5 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.


Biospecimen Retention:   Samples With DNA
Biopsies from the gastrointestinal (GI) tract may be collected and used to learn more about eosinophilic gastrointestinal disorders. Genetic analysis may be performed on some of these samples.

Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males and females ages 3 or greater with EoE, EG, EGE or EC.

*This study is not currently enrolling EG patients but is accepting new EoE, EGE and EC patients for participation.

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523118


Contacts
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Contact: Kara Kliewer, PhD 513-636-4821 Kara.kliewer@cchmc.org

Locations
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Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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)
Investigators
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Principal Investigator: Marc E Rothenberg, MD, PhD Children's Hospital Medical Center, Cincinnati
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02523118    
Other Study ID Numbers: 2015-2311
U54AI117870 ( Other Grant/Funding Number: NIDDK )
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: December 2022
Additional relevant MeSH terms:
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Colitis
Esophagitis
Gastroenteritis
Eosinophilic Esophagitis
Gastritis
Gastrointestinal Diseases
Digestive System Diseases
Enteritis
Eosinophilia
 Colonic Diseases
Intestinal Diseases
Esophageal Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Stomach Diseases