Outcome Measures for EGIDs

(OMEGA Trial)

Recruiting at 15 trial locations

Overseen By Bliss Magella

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Intestinal surgery, Blinded study, Esophageal stricture, Infections, GI cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to identify the best methods for tracking the progress of individuals with eosinophilic gastrointestinal disorders. These disorders affect the digestive system and involve an abnormal number of eosinophils, a type of white blood cell. The study examines the relationship between different tissue components and symptoms and evaluates whether standard questionnaires can effectively assess a patient's condition. This observational study suits individuals over three years old with a known eosinophilic disorder who are experiencing related symptoms. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance future care and understanding of their condition.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the OMEGA trial because it aims to provide a comprehensive understanding of eosinophilic gastrointestinal disorders (EGIDs) across different age groups. Unlike treatments that focus solely on managing symptoms, this observational study seeks to uncover the underlying patterns and progression of the condition throughout a person's life. By gathering detailed data on how EGIDs affect individuals at various stages, the trial could lead to more personalized and effective treatment strategies in the future.

Who Is on the Research Team?

Marc E Rothenberg, MD, PhD

Principal Investigator

Cincinnati Children's Hospital Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Participants undergo standard of care endoscopies and/or colonoscopies with biopsies collected for research. They also complete questionnaires related to symptoms and quality of life.

10 years

Follow-up

Participants are monitored for changes in mucosal eosinophil levels and correlation with clinical outcome measures over time.

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Observational Study

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

ORDR

Collaborator

Trials

1

Recruited

1,400+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+