Esophageal String Test in Eosinophilic Esophagitis

May 13, 2026 updated by: University of Colorado, Denver

Phase 2 Study of Esophageal String Test in Diagnosing Eosinophilic Esophagitis

The overall goal of this study is to develop a novel minimally invasive device, the Esophageal String Test (EST) to monitor esophageal inflammation during treatment of the rare disease Eosinophilic Esophagitis (EoE) in a safe and efficacious manner.

This study is broken down into 2 specific aims:

Specific Aim 1: Identify the EoE Biomarker Panel (EBP) that will improve the sensitivity and specificity of the EST for documenting esophageal inflammation in a 1-hour time point.

Specific Aim 2: Validate the ability of the EST EBP to monitor therapeutic efficacy in a 1-hour sampling time.

Funding Source - FDA OOPD

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Eosinophilic esophagitis (EoE) is an increasingly recognized rare disease of children and adults characterized by symptoms including nausea, vomiting, abdominal pain, dysphagia and food impaction that occur in conjunction with esophageal eosinophilia. To date, the only method to make EoE diagnoses and follow treatment responses in EoE is invasive endoscopy with biopsy. While endoscopy is generally safe, an accurate, less invasive, inexpensive, comprehensive and durable test is urgently needed to determine therapeutic efficacy. To address this need, the investigators will use a novel application of an existing technology, the Enterotest™ (a string-based test used to detect intestinal Giardiasis), to measure esophageal inflammation (herein termed the Esophageal String Test - EST). The investigators supportive Preliminary Data provide proof-of-principle for the ability of ESTs to capture esophageal inflammatory mediators in luminal samples from patients affected with EoE. The investigators prospective study demonstrates that: (1) levels of eosinophil-derived granule proteins (MBP1, EDN, ECP, EPX, CLC/Gal-10) in esophageal mucosal biopsies correlate with levels quantitated in EST-captured samples, i.e., levels in luminal secretions captured by the EST correlate with mucosal inflammation, and (2) these luminal biomarkers of eosinophilic inflammation significantly correlate with EoE disease activity. These findings provide strong support for using ESTs as novel minimally invasive instruments to monitor therapeutic efficacy in EoE. The global objective of this project is therefore to bring the "Esophageal String Test" (EST) to commercialization, so that it can be used to monitor therapeutic efficacy in children and adults with EoE. The investigators hypothesize that ESTs will capture an EoE Biomarker Panel (EBP) reflective of disease activity. The Specific Aims are to: (1) Identify an EoE Biomarker Panel (EBP) that will improve the sensitivity and specificity of the EST for monitoring disease activity and (2) Validate the ability of the EST EBP to monitor therapeutic efficacy in 1-hour sampling time. The investigators supportive Preliminary Data demonstrate the feasibility of using ESTs in both children and adults with EoE to measure disease activity (esophageal inflammation) in an overnight (12-hour) test, and shorter time periods, currently performed before a scheduled endoscopy with biopsy. In this project, The investigators propose to shorten this time frame to a 1-hour test, a clinically relevant time point that will markedly facilitate its use and potential impact in the outpatient clinic setting.

Public Health Relevance/Impacts: At least four major impacts should result from these studies:

(1) Identification of an EBP will permit monitoring of esophageal inflammation in EoE; (2) the EBP will be relevant to following disease progression, treatment responses, management and pathogenesis of EoE, (3) validation of the EST EBP will enable development of rapid and inexpensive assays to follow treatment responses, thus reducing the number of follow-up endoscopies with biopsy that are currently performed, and (4) provide a device to monitor EoE disease activity where endoscopy with biopsy may not be available or affordable.

Study Type

Observational

Enrollment (Estimated)

440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Lurie Children's Hospital
      • Chicago, Illinois, United States, 60601
        • Northwestern University
      • Peoria, Illinois, United States, 61603
        • OSF St Francis Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Any pediatric or adult patient undergoing a clinically indicated endoscopy with biopsy at a participating site may be recruited. (initial cohort)

Description

Inclusion Criteria:

  • Patients undergoing esophagogastroduodenoscopy (EGD) at Children's Hospital Colorado, or
  • Patients from a participating site in whom an inflammatory GI disease is suspected.

  • Patients with symptoms of:

    1. abdominal pain,
    2. vomiting,
    3. growth delay, or
    4. malabsorption for which an etiology has not been determined.
  • Patients with chronic eosinophilic esophagitis (EoE) in whom symptoms suggest ongoing inflammation.

Exclusion Criteria:

  • Patients suffering from bleeding diathesis, or any other comorbid condition which their doctor feels may put them at additional risk.
  • Patients with a family history of connective tissue disease.
  • Patients undergoing a therapeutic endoscopy (such as dilatation, sclerotherapy, variceal banding).

  • Patients with a history of:

    1. esophageal stricture, or
    2. surgery such as fundoplication, or
    3. allergy to gelatin, or
    4. inability to swallow pills.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
EoE active disease
Inflammation as defined by >15 eos / HPF
EoE remission
No inflammation in EoE patients after treatment
normal control
No inflammation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association of biomarker levels in biopsy tissue with pathological findings (eosinophil counts)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation for the level of each biomarker between EST and tissue biopsy samples
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Ability of an individual biomarker (or combination of biomarkers) to differentiate mucosal biopsy EBP sample obtained before and after treatment
Time Frame: 12 weeks
12 weeks
Ability of an individual biomarker (or combination of biomarkers) to differentiate post-treatment mucosal biopsy EBP sample from normal control
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Northwestern University
University of Illinois at Chicago
OSF Healthcare System

Investigators

  • Principal Investigator: Glenn T Furuta, MD, Children's Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimated)

December 11, 2013

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0223
  • FD-R-G04086-01 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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