OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
| Status: | Recruiting | 
|---|---|
| Conditions: | Colitis, Gastrointestinal, Gastrointestinal, Digestive Disease | 
| Therapuetic Areas: | Gastroenterology | 
| Healthy: | No | 
| Age Range: | 3 - Any | 
| Updated: | 1/12/2019 | 
| Start Date: | July 2015 | 
| End Date: | January 2051 | 
| Contact: | Heidi Poppendeck, MPH | 
| Email: | heidi.poppendeck@cchmc.org | 
| Phone: | 513-803-3078 | 
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) and Colitis (EC)
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.
			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.
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.
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.
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)
We found this trial at
    15
    sites
	
									9000 Rockville Pike
Bethesda, Maryland 20892
	
			
					Bethesda, Maryland 20892
Principal Investigator: Paneez Khoury, MD
			
						
										Phone: 301-402-5969
					Click here to add this to my saved trials
	
								Chapel Hill, North Carolina 27599			
	
			(919) 962-2211 
							
					Principal Investigator: Evan Dellon, M.D., MPH
			
						
										Phone: 919-843-0688
					
		University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...  
  
  Click here to add this to my saved trials
	
									3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
	
			Cincinnati, Ohio 45229
 1-513-636-4200  
							
					Phone: 513-803-3078
					
		Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...  
  
  Click here to add this to my saved trials
	
									South 34th Street
Philadelphia, Pennsylvania 19104
	
			Philadelphia, Pennsylvania 19104
 215-590-1000 
							
					Principal Investigator: Jonathan Spergel, MD, PhD
			
						
										Phone: 215-590-2549
					
		Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...  
  
  Click here to add this to my saved trials
	
									201 Presidents Circle
Salt Lake City, Utah 84108
	
			Salt Lake City, Utah 84108
801) 581-7200 
							
					Principal Investigator: Kathryn Peterson, MD
			
						
										Phone: 801-587-9050
					
		University of Utah Research is a major component in the life of the U benefiting...  
  
  Click here to add this to my saved trials
	
									13001 E. 17th Pl
Aurora, Colorado 80045
	
			Aurora, Colorado 80045
303-724-5000
							
					Principal Investigator: Paul Menard-Katcher, MD
			
						
										Phone: 303-724-8974
					
		University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...  
  
  Click here to add this to my saved trials
	
								Boston, Massachusetts 02111			
	
			
					Principal Investigator: John Leung, M.D.
			
						
										Phone: 617-636-4941
					Click here to add this to my saved trials
	
									303 East Superior Street
Chicago, Illinois 60611
	
			
					Chicago, Illinois 60611
Principal Investigator: Ikuo Hirano, M.D.
			
						
										Phone: 312-695-4036
					Click here to add this to my saved trials
	
									225 E Chicago Ave
Chicago, Illinois 60611
	
			Chicago, Illinois 60611
(312) 227-4000
							
					Principal Investigator: Barry Wershil, M.D.
			
						
										Phone: 312-227-4546
					
		Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children  
  
  Click here to add this to my saved trials
	
								Denver, Colorado 80045			
	
			
					Principal Investigator: Glenn Furuta, M.D.
			
						
										Phone: 720-777-5739
					Click here to add this to my saved trials
	
								Houston, Texas 			
	
			
					Principal Investigator: Carla Davis, MD
			
						
										Phone: 832-824-0939
					Click here to add this to my saved trials
	
									9500 Gilman Dr
La Jolla, California 92093
	
			La Jolla, California 92093
(858) 534-2230
							
					Principal Investigator: Seema Aceves, M.D., PhD
			
						
										Phone: 858-657-5131
					
		The University of California, San Diego UC San Diego is an academic powerhouse and economic...  
  
  Click here to add this to my saved trials
	
									1428 Madison Ave
New York, New York 10029
	
			New York, New York 10029
(212) 241-6500
							
					Principal Investigator: Mirna Chehade, MD
			
						
										Phone: 212-241-8780
					
		Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...  
  
  Click here to add this to my saved trials
	
									4810 North Sheridan Road
Peoria, Illinois 61613
	
			
					Peoria, Illinois 61613
Principal Investigator: Sandeep Gupta, MD
			
						
										Phone: 309-624-7552
					Click here to add this to my saved trials
	
									3451 Walnut St
Philadelphia, Pennsylvania 19104
	
			Philadelphia, Pennsylvania 19104
1 (215) 898-5000 
							
					Principal Investigator: Gary Falk, M.D., MS
			
						
										Phone: 215-349-8546
					
		Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...  
  
  Click here to add this to my saved trials