Esophageal String Test in Eosinophilic Esophagitis



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:7 - 65
Updated:10/11/2018
Start Date:January 2009
End Date:June 2020
Contact:Kendra Kocher
Email:kendra.kocher@childrenscolorado.org
Phone:720-777-5304

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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

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 Enterotestâ„¢ (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.

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.
We found this trial at
6
sites
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Paul Menard-Katcher, MD
Phone: 303-724-8974
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Sandeep Gupta, MD
Phone: 317-944-1421
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-2797
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Ikuo Hirano, MD
Phone: 312-695-4054
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Chicago, IL
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Chicago, Illinois 60611
Principal Investigator: Amir F Kagalwalla, MBBS
Phone: 312-227-4656
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Chicago, IL
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530 NE Glen Oak Ave
Peoria, Illinois 61637
(309) 655-2000
Principal Investigator: Sandeep Gupta, MD
Phone: 309-624-4087
OSF St. Francis Medical Center OSF Saint Francis Medical Center, licensed for 616 beds and...
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Peoria, IL
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