Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis

March 28, 2023 updated by: University of Colorado, Denver

Non-endoscopic Tracking of Disease Activity During Dietary Interventions in Eosinophilic Esophagitis

To prospectively determine the natural history of inflammation resolution following initiation of diet treatment and to optimize the diet treatment of patients with EoE through the use of a non-endoscopic tracking device, the esophageal string test (EST).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an adult and pediatric prospective, longitudinal study in which we will measure symptoms, QOL and inflammation at baseline and again at 2, 4 and 6 weeks after starting stand of care (SOC) four food elimination diet (FFED) (Aim 1). Newly or previously diagnosed patients with EoE with active disease who will be undergoing SOC FFED will be offered entry into the study by the PI's or their local co-investigators at each of their institutions. EoE patients who are in remission on SOC FFED from Aim 1 will be recruited to participate in this food reintroduction trial in Aim 2. Eligible subjects will undergo SOC sequential food reintroductions and during the food introduction, ESTs will be performed at 2 and 4 week intervals during a clinic visit. If inflammation is detected by the EST, this food will be eliminated from the diet for six weeks and a repeat EST will be administered at this time to assess inflammation. If inflammation has resolved based on EST results, food reintroduction will resume. If no inflammation is detected by the EST at the 4 week interval, a new food will be added. EST will be performed after each food reintroduction as outlined above. Based on known allergenic properties of these foods, the order of food reintroduction will be soy, eggs, wheat and milk.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant must be able to understand and provide informed consent
  • Males and Females ≥7 years of age to 65 years of age
  • Have diagnosis of EoE
  • Have histologically confirmed active disease ≥15 eosinophils/hpf
  • Symptomatic (have experienced symptoms within the last one months prior to enrollment).
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry
  • Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study

Exclusion Criteria:

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Secondary causes of eosinophilia
  • Pregnancy
  • Immunodeficiency states
  • Have participated in any investigative drug study within 6 weeks prior to study entry
  • Unable to complete study procedures including endoscopy
  • Luminal stricture identified <13mm which would prevent passage of the EST and prevent assessment of mucosal inflammation
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Four Food Elimination Diet (FFED)
There is one arm to the study. All participants meeting eligibility will be assigned to intervention / treatment with a previously defined four food elimination diet (FFED) (Aim 1). This is a longitudinal study in which outcome measures including symptoms, QOL and inflammation at baseline and at 2, 4 and 6 weeks after starting stand of care (SOC) FFED will be measured. Participants meeting eligibility for Aim 2 will have foods added back to the diet using a specified protocol.
Other: Four Food Elimination Diet
Food allergens are thought to initiate eosinophilic inflammation and dietary elimination of trigger allergens is an effective treatment for EoE. Previous work demonstrates that in both children and adult EoE patients, the food antigens including cow's milk, wheat, egg, soy, peanut/tree nut and fish/shell fish, are the most common food triggers causing esophageal inflammation. Participants will be assigned to single arm treatment / intervention with a diet restricted of the four most common food allergens, milk, soy, wheat and egg, or a four food elimination diet (FFED). With the goal to optimize diet treatment, in Aim 2, eligible participants will undergo sequential food reintroductions based on protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
Time Frame: 6 weeks
Disease remission will be an EoEScore <0.36, the score below which the patient has a very low probability of having an eosinophil count > 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE.
6 weeks
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
Time Frame: 2 weeks
Disease remission will be an EoEScore <0.36, the score below which the patient has a very low probability of having an eosinophil count > 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE. This 2 week time point will be a co-primary outcome measure.
2 weeks
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
Time Frame: 4 weeks
Disease remission will be an EoEScore <0.36, the score below which the patient has a very low probability of having an eosinophil count > 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE. This 4 week time point will be a co-primary outcome measure.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)
Time Frame: Baseline and 6 weeks
The validated symptoms severity assessment tool Eosinophilic Esophagitis Activity Index (EESAI) will be used to assess severity in participants age 18 to 65.
Baseline and 6 weeks
Change in Symptom Severity in Participants Age 7-18 as Measured by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.)
Time Frame: Baseline and 6 weeks
The validated symptoms severity assessment tool Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.) will be used to assess severity in participants age 7 to 18.
Baseline and 6 weeks
Time to Disease Recurrence as Measured by EST score
Time Frame: 4 weeks after food re-introduction
To determine the time to disease recurrence with re-introduction of potential food allergen triggers, disease recurrence will be indicated by an EoEScore probability of > 0.53.
4 weeks after food re-introduction
Time to Disease Recurrence as Measured by EST score
Time Frame: 2 weeks after food re-introduction
To determine the time to disease recurrence with re-introduction of potential food allergen triggers, disease recurrence will be indicated by an EoEScore probability of > 0.53.
2 weeks after food re-introduction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northwestern University
Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-0018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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