FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

Esophageal String Test in Eosinophilic Esophagitis

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Yes

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 7 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02008903

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of Colorado, Denver

The person who is responsible for the scientific and technical direction of the entire clinical study.

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

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherOtherOther
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Eosinophilic Esophagitis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

University of Colorado Hospital, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Hospital

Aurora, Colorado, 80045

Site Contact

Jonathon Cahoon

jonathon.cahoon@ucdenver.edu

303-724-8974

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60601

Site Contact

Angelika Zalewski

angelika.zalewski@northwestern.edu

312-695-4054

Lurie Children's Hospital, Chicago, Illinois

Status

Recruiting

Address

Lurie Children's Hospital

Chicago, Illinois, 60611

Site Contact

Katie Keeley

kkeeley@luriechildrens.org

312-227-4656

OSF St Francis Medical Center, Peoria, Illinois

Status

Recruiting

Address

OSF St Francis Medical Center

Peoria, Illinois, 61603

Site Contact

Jocelyn T Perry, RN

Jocelyn.K.Perry@osfhealthcare.org

309-624-4087

Indiana University, Indianapolis, Indiana

Status

Completed

Address

Indiana University

Indianapolis, Indiana, 46202

Site Contact

720-777-5304

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