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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 (EG) and Colitis (EC)

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 (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.

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Inclusion Criteria:

Males or females 3 years of age and older

If subject does not have an already established diagnosis of EoE, EG, EGE, or EC, must have ongoing clinical symptoms. Symptoms include, but are not limited to:

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

-EG - abdominal pain, vomiting

-EGE-abdominal pain, vomiting diarrhea

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

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

-For EoE subjects>=15 eosinophils/hpf in the distal or proximal esophagus.

-For EG subjects, >=30 eosinophils/hpf in 5 hpf's in the body and/or antrum

-For EGE subjects, >=53 eosinophils/hpf in the duodenum and/or >=56 eosinophils/hpf in the jejunum and/or ileum

-For EC subjects, >=84 eosinophils/hpf from the transverse or descending colong and/or >=32 eosinophils/hpf from the rectosigmoid colon or a biopsy from any colonic location with >=100 eosinophils/hpf

Subjects with EC enrolled prior to Protocol Version 5.0 with <65 eosinophils in the rectosignoid colon but have >=32 eosinophils/hpf from the rectosigmoid colo

Exclusion Criteria:

History of intestinal surgery other than G tube placement

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

Esophageal stricture <3mm

Subjects with other identifiable potential causes for eosinophilia except 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 EC, then the potential subject could enroll if all other inclusion/exclusion criteria are met.

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 thta the potential subject has diminished capacity and is not cognitively able to participate fully in the consenting process.

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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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