Clinical trial NCT02897271: Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort
Official title: Demographics, Clinical Characteristics, and Pathology of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic Colitis
Keywords: Eosinophilic Gastrointestinal Disorders
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Office of Rare Diseases (ORD)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2016-09-13
Enrollment: 381
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients of any age with a diagnosis of eosinophilic gastrointestinal disorder (EGID) other than eosinophilic esophagitis (EoE) alone, including eosinophilic gastritis (EG), eosinophilic gastroenteritis (EGE), and eosinophilic colitis (EC).

Brief summary: The purpose of this study is to investigate features of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).

Detailed description: This retrospective chart review study will analyze the demographics, medical history, clinical features, and pathological data of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of an EGID including EG, EGE, and/or EC. Subjects with EoE can be included if they also have another EGID.
* Clinical symptoms of gastrointestinal dysfunction.
* Findings of increased eosinophils on tissue biopsy at the time of diagnosis, before treatment initiated.
* Exclusion of other causes of gastrointestinal eosinophilia.

Exclusion Criteria:

* Gastrointestinal eosinophilia caused by another disorder.
* Diagnosis of EoE without another EGID.
* Insufficient medical record or pathology data available to support an EGID diagnosis.

Primary outcomes:
measure: Mucosal eosinophilia (eos/hpf)
timeFrame: Duration of funding, approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Science
state: Arkansas
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marc E Rothenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: