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Protocol Details

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)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Gastrointestinal Disorders;
Eosinophilic Gastroenteritis;
Mucosal Eosinophil Count;
Natural History

Recruitment Keyword(s)



Eosinophilic Esophagitis (EoE);
Eosinophilic Gastroenteritis (EGE);
Eosinophilic Colitis (EC);
Eosinophilic Gastritis (EoG)

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Allergy and Infectious Diseases

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 (EoG), eosinophilic enteritis (EoN), and eosinophilic colitis (EoC) 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.

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Individuals who meet all of the following criteria are eligible for enrollment as study participants:

-Males or females >= 3 years of age.

-If subject does not have an already established diagnosis of EoE, EoG, EoN, or EoC, must have ongoing clinical symptoms.

Symptoms include, but are not limited to:

-EoE-abdominal pain, vomiting, heartburn, feeding / eating problems, dysphagia, food impaction,

-EoG- abdominal pain, vomiting,

-EoN- abdominal pain, vomiting, diarrhea

-EoC- hematochezia, bloody/non bloody diarrhea, tenesmus, abdominal pain

Symptoms are not required for subjects with established EoE, EoG, EoN or EoC diagnoses. Symptoms are required for new EGID diagnoses; new diagnoses are defined as receiving a diagnostic endoscopy within 4 weeks of study enrollment.

-Mucosal eosinophilia peak counts reaching the following thresholds in a diagnostic endoscopy:

--For EoE subjects, (Bullet) 15 eosinophils/hpf in the distal or proximal esophagus.

--For EoG subjects, (Bullet) 30 eosinophils/hpf in 5 hpf s in the body and/or antrum

--For EoN subjects, (Bullet) 53 eosinophils/hpf in the duodenum and/or (Bullet) 56 eosinophils/hpf in the jejunum and/or ileum

--For EoC subjects, (Bullet) 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.

Peak eosinophilia counts are based on the current diagnosing guidelines. These thresholds are subject to change as new research develops and guidelines are updated.


Individuals who meet any of these criteria are not eligible for enrollment as study subjects:

-Currently enrolled in a blinded investigational study at the time of the screening/enrollment/baseline visit.

-Subjects with other identifiable potential causes for eosinophilia such as some cancers, intestinal worm and parasite infections and graft versus host disease.

-Any physical, mental or social condition, history or concurrent illness or laboratory abnormality that, in the investigator s judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study.

-Potential subjects will be excluded if the investigator determines that the potential subject has diminished capacity and is not cognitively able to participate fully in the consenting process

-Subjects with inflammatory bowel disease (IBD). In the case of IBD, investigators will review the clinical history, serology and accompanying biopsies to determine if the diagnosis captures UC/Crohn s diagnosis in the context of the histological finding of mucosal eosinophilia. If the assessment suggests that the subject clearly has ulcerative colitis or Crohn s disease, the subject will not be enrolled. If the assessment suggests the subject may have EoC, then the potential subject could enroll if all other inclusion/exclusion criteria are met.

Subjects can enter blinded investigational trials at any point after completion of the baseline visit. The study team will record the dates of trial participation and continue to collect OMEGA study data during the period the subject participates in the trial.

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Furuta GT, Liacouras CA, Collins MH, Gupta SK, Justinich C, Putnam PE, Bonis P, Hassall E, Straumann A, Rothenberg ME; First International Gastrointestinal Eosinophil Research Symposium (FIGERS) Subcommittees. Eosinophilic esophagitis in children and adults: a systematic review and consensus recommendations for diagnosis and treatment. Gastroenterology. 2007 Oct;133(4):1342-63. Epub 2007 Aug 8.

Zuo L, Rothenberg ME. Gastrointestinal eosinophilia. Immunol Allergy Clin North Am. 2007 Aug;27(3):443-55.

Aceves S, Hirano I, Furuta GT, Collins MH. Eosinophilic gastrointestinal diseases--clinically diverse and histopathologically confounding. Semin Immunopathol. 2012 Sep;34(5):715-31. doi: 10.1007/s00281-012-0324-x. Epub 2012 Jul 29.

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Principal Investigator

Referral Contact

For more information:

Paneez Khoury, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 402-3673

Nicole C. Holland-Thomas, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6D44.18
10 Convent Drive
Bethesda, Maryland 20892
(301) 402-5969

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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