Eosinophilic EsophagitisNCT02008903
Esophageal String Test in Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by University of Colorado, Denver at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- How many people
- 440 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2009to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any pediatric or adult patient undergoing a clinically indicated endoscopy with biopsy at a participating site may be recruited. (initial cohort)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Hospital
Aurora, Colorado, 80045
Northwestern University
Chicago, Illinois, 60601
Lurie Children's Hospital
Chicago, Illinois, 60611
Indiana University
Indianapolis, Indiana, 46202
OSF St Francis Medical Center
Peoria, Illinois, 61603
About this study
Official title: 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
Read the 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.
- Conditions
- Eosinophilic Esophagitis
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Association of biomarker levels in biopsy tissue with pathological findings (eosinophil counts)
Measured: 12 weeks
Secondary outcomes (1)
Correlation for the level of each biomarker between EST and tissue biopsy samples
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2009
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Chicago, Northwestern University, OSF Healthcare System
- Responsible party
- Sponsor
- Investigators
- Glenn T Furuta, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008903
- Sponsor's protocol ID
- 07-0223
- Other IDs
- FD-R-G04086-01
- Status last verified
- May 2026
- First submitted
- 6 Dec 2013
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39503361Furuta 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.
PubMed 22895393Ackerman 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.
PubMed 31567192
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Esophageal String Test in Diagnosing Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02008903
- Acronym / sponsor ID
- 07-0223
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Illinois at Chicago, Northwestern University, OSF Healthcare System
- Study start
- Jan 2009
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EoE active disease | – | –Inflammation as defined by >15 eos / HPF |
| EoE remission | – | –No inflammation in EoE patients after treatment |
| normal control | – | –No inflammation |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any pediatric or adult patient undergoing a clinically indicated endoscopy with biopsy at a participating site may be recruited. (initial cohort)
Key inclusion criteria (8 listed)
- 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:
- Patients with chronic eosinophilic esophagitis (EoE) in whom symptoms suggest ongoing inflammation.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of biomarker levels in biopsy tissue with pathological findings (eosinophil counts)
Time frame: 12 weeks
1 secondary outcome
Correlation for the level of each biomarker between EST and tissue biopsy samples
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publication: PubMed 39503361Ackerman 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.
- Results publication: PubMed 22895393Furuta 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.
- Results publication: PubMed 31567192Ackerman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn T Furuta, MD principal investigator
Children's Hospital Colorado
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by University of Colorado, Denver at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of biomarker levels in biopsy tissue with pathological findings (eosinophil counts) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02008903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.