Esophageal String Test in Eosinophilic Esophagitis

NCT02008903 | Active Not Recruiting

• 2 other identifiers: 07-0223FD-R-G04086-01
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Association of biomarker levels in biopsy tissue with pathological findings (eosinophil counts)

  12 weeks

Secondary Outcomes (1)

• Correlation for the level of each biomarker between EST and tissue biopsy samples

  12 weeks

Other Outcomes (2)

• Ability of an individual biomarker (or combination of biomarkers) to differentiate mucosal biopsy EBP sample obtained before and after treatment

  12 weeks

• Ability of an individual biomarker (or combination of biomarkers) to differentiate post-treatment mucosal biopsy EBP sample from normal control

  12 weeks

Study Arms (3)

EoE active disease

Inflammation as defined by \>15 eos / HPF

EoE remission

No inflammation in EoE patients after treatment

normal control

No inflammation

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• 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:
• esophageal stricture, or
• surgery such as fundoplication, or
• allergy to gelatin, or
• inability to swallow pills.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Illinois at Chicago: collaborator
• OSF Healthcare System: collaborator
• Northwestern University: collaborator

Study Sites (6)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60601, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

OSF St Francis Medical Center

Peoria, Illinois, 61603, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

• Ackerman SJ, Kagalwalla AF, Pan Z, Wechsler J, Keeley K, Gonsalves N, Hirano I, Zalewski A, Menard-Katcher P, Menard-Katcher C, Gupta SK, Chauhan N, Grozdanovic M, Atkins D, Nguyen N, Furuta GT. The Minimally Invasive 1-Hour Esophageal String Test Monitors Therapeutic Changes in Mucosal Inflammation in Eosinophilic Esophagitis. Am J Gastroenterol. 2025 Jan 1;120(1):254-258. doi: 10.14309/ajg.0000000000003192. Epub 2024 Nov 6.

  PMID: 39503361 RESULT

• 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.

  PMID: 22895393 RESULT

• 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.

  PMID: 31567192 RESULT

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Glenn T Furuta, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: January 1, 2009
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)