OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females 3 years of age and older

Disqualifiers

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 population

Males and females ages 3 or greater with EoE, EoG, EoN or EoC.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Duration of funding, at least 10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

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

Collaborator

ORDR

Collaborator

National Center for Advancing Translational Sciences (NCATS)

Collaborator