ClinicalTrials.gg
CompletedNCT02897271Updated Sep 28, 2021

Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort

An observational study in Eosinophilic Esophagitis, Eosinophilic Gastritis and Eosinophilic Gastroenteritis, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 6 sites in United States. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by Children's Hospital Medical Center, Cincinnati · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
381
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Eosinophilic Esophagitis by Children's Hospital Medical Center, Cincinnati — 3 open to participants now, 3 under way, none of them phase 3. Eosinophilic Esophagitis · Children's Hospital Medical Center, Cincinnati.

Started
2016
with 2 others
Observational
5 of 13
2 open now
Registered
8th of 13
by date

Among the 13 studies in Eosinophilic Esophagitis by Children's Hospital Medical Center, Cincinnati, this one is one of 3 that started in 2016, is one of 5 observational ones, and was the 8th registered.

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

Browse Eosinophilic Esophagitis studies →

Open to participants now

3 of the 13 studies in Eosinophilic Esophagitis by Children's Hospital Medical Center, Cincinnati are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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).

Read the 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).

03

Conditions studied

  • Eosinophilic Esophagitis
  • Eosinophilic Gastritis
  • Eosinophilic Gastroenteritis
  • Eosinophilic Colitis

Keywords

  • Eosinophilic Gastrointestinal Disorders
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 at the time of diagnosis, before treatment initiated.
  • Exclusion of other causes of gastrointestinal eosinophilia.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
381 participants (actual)
Patient registry
No
06

What researchers measure

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 other measures of disease activity.

    Time frame: Duration of funding, approximately 5 years

07

Study locations

6 sites
  • University of Arkansas for Medical Science
    Little Rock, Arkansas 72205, United States
  • Children's Hospital Colorado
    Denver, Colorado 80218, United States
  • University of North Carolina, Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2016, a primary completion of Sep 2019 and a completion of May 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2016
First posted
Sep 13, 2016
Start
Aug 2016
Primary completionActual
Sep 2019
CompletionActual
May 2020
Last update
Sep 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02897271
Responsible party
Sponsor
First posted
Sep 13, 2016
Start date
Aug 2016
Primary completion
Sep 2019
Completion
May 2020
Last update
Sep 28, 2021

Study contacts

Marc E Rothenberg, MD, PhD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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