ClinicalTrials.gg
RecruitingNCT02453126Updated Feb 5, 2024

Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

An observational study in Eosinophilic Esophagitis, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by University of Colorado, Denver · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
250
Ages
5 Years to 18 Years
Sex
All
01

Where this study stands

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

Among 165 studies in Eosinophilic Esophagitis with a site in United States — 23 open to participants now, 41 under way, 3 of them phase 3. Eosinophilic Esophagitis · United States.

Planned enrollment
19th of 53
250 · median 80
Started
2014
with 12 others
Observational
53 of 165
13 open now
Primary completion
2024-06
later than 5 of 40 live
Registered
59th of 165
by date
Lead sponsor
6 of 165
University of Colorado, Denver

Among the 165 studies in Eosinophilic Esophagitis with a site in United States, this one is the 19th largest by planned enrollment of the 53 observational ones that give a count, is one of 13 that started in 2014, is one of 53 observational ones, reaches primary completion later than 5 of the 40 other live ones, and was the 59th 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

23 of the 165 studies in Eosinophilic Esophagitis with a site in United States are open now. Recruiting first, the newest first:

17 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

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: 5 Years to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis (EoE) is characterized by abnormal esophageal structure and compliance compared to non fibrostenotic EoE and that distinctive cellular and molecular profiles predict the fibrostenotic phenotype. This study aims to define and assess the changes that occur in the structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along with characterizing the histologic and molecular patterns in fibrostenotic EoE.

03

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • Eosinophilic Esophagitis
  • Esophageal Stricture
04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children, ages 5 to 18 years, scheduled to undergo a clinical upper endoscopy with biopsy for suspected or confirmed Eosinophilic Esophagitis.

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

  • Scheduled to undergo a clinical upper endoscopy with

Exclusion criteria

Exclusion Criteria:

  • Known connective tissue disorder
  • Increased risk of bleeding
  • Inflammatory bowel disease, celiac disease, eosinophilic gastroenteritis, or any disease
  • Other esophageal disease including known achalasia; history of caustic ingestion, esophageal surgery esophageal stricture for other known reason or other esophageal injury.
  • Use of oral or intravenous in the preceding 60 days. (Swallowed topical fluticasone, budesonide, etc not included as exclusion criteria.)
Terms in these criteria, in plain language(3)

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Stricture, as measured by endoscopic assessment

    Time frame: Day 1

Secondary outcomes

  1. Decreased esophageal distensibility, as determined by EndoFlip

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

Timeline

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

The record gives a start of Dec 2014, a primary completion of Jun 2024 and a completion of Jun 2024. 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 16, 2014
First posted
May 25, 2015
Start
Dec 2014
Primary completionEst.
Jun 2024
CompletionEst.
Jun 2024
Last update
Feb 5, 2024
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 Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02453126
Responsible party
Sponsor
First posted
May 25, 2015
Start date
Dec 2014
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Feb 5, 2024

Study contacts

Cassandra Burger
Contact
cassandra.burger@childrenscolorado.org
720-777-5739
Calies Menard-Katcher, MD
principal investigator · University of Colorado/Childrens Hospital Colorado

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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