Esophageal String Test in Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

Phase 2 Study of Esophageal String Test in Diagnosing Eosinophilic Esophagitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02008903
• Other study ID #: 07-0223
• Secondary ID: FD-R-G04086-01
• Status: Active, not recruiting
• Start date: January 2009
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Indiana University	Indianapolis	Indiana
United States	OSF St Francis Medical Center	Peoria	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Northwestern University, OSF Healthcare System, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ackerman SJ, Kagalwalla AF, Hirano I, Gonsalves N, Katcher PM, Gupta S, Wechsler JB, Grozdanovic M, Pan Z, Masterson JC, Du J, Fantus RJ, Alumkal P, Lee JJ, Ochkur S, Ahmed F, Capocelli K, Melin-Aldana H, Biette K, Dubner A, Amsden K, Keeley K, Sulkowski M, Zalewski A, Atkins D, Furuta GT. One-Hour Esophageal String Test: A Nonendoscopic Minimally Invasive Test That Accurately Detects Disease Activity in Eosinophilic Esophagitis. Am J Gastroenterol. 2019 Oct;114(10):1614-1625. doi: 10.14309/ajg.0000000000000371. — View Citation

Furuta GT, Kagalwalla AF, Lee JJ, Alumkal P, Maybruck BT, Fillon S, Masterson JC, Ochkur S, Protheroe C, Moore W, Pan Z, Amsden K, Robinson Z, Capocelli K, Mukkada V, Atkins D, Fleischer D, Hosford L, Kwatia MA, Schroeder S, Kelly C, Lovell M, Melin-Aldana H, Ackerman SJ. The oesophageal string test: a novel, minimally invasive method measures mucosal inflammation in eosinophilic oesophagitis. Gut. 2013 Oct;62(10):1395-405. doi: 10.1136/gutjnl-2012-303171. Epub 2012 Aug 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ability of an individual biomarker (or combination of biomarkers) to differentiate mucosal biopsy EBP sample obtained before and after treatment		12 weeks
Other	Ability of an individual biomarker (or combination of biomarkers) to differentiate post-treatment mucosal biopsy EBP sample from normal control		12 weeks
Primary	Association of biomarker levels in biopsy tissue with pathological findings (eosinophil counts)		12 weeks
Secondary	Correlation for the level of each biomarker between EST and tissue biopsy samples		12 weeks