Eosinophilic EsophagitisNCT03834298
Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis
A study testing Four Food Elimination Diet in people with Eosinophilic Esophagitis, run by University of Colorado, Denver.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Four Food Elimination Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Four Food Elimination Diet
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four Food Elimination DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Four Food Elimination Diet (FFED) | Experimental | 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. Receives: Other: Four Food Elimination Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
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.
Measured: 6 weeks
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
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.
Measured: 2 weeks
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
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.
Measured: 4 weeks
Secondary outcomes (4)
Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)
The validated symptoms severity assessment tool Eosinophilic Esophagitis Activity Index (EESAI) will be used to assess severity in participants age 18 to 65.
Measured: Baseline and 6 weeks
Change in Symptom Severity in Participants Age 7-18 as Measured by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.)
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.
Measured: Baseline and 6 weeks
Time to Disease Recurrence as Measured by EST score
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.
Measured: 4 weeks after food re-introduction
Time to Disease Recurrence as Measured by EST score
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.
Measured: 2 weeks after food re-introduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Jun 2021 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Study grant not obtained; not moving forward with study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Sponsor
- Investigators
- Calies Menard-Katcher, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834298
- Sponsor's protocol ID
- 19-0018
- Status last verified
- Mar 2023
- First submitted
- 4 Jan 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-endoscopic Tracking of Disease Activity During Dietary Interventions in Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT03834298
- Acronym / sponsor ID
- 19-0018
- Conditions
- Eosinophilic Esophagitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study grant not obtained; not moving forward with study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Northwestern University, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Feb 2019 (actual)
- 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.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Four Food Elimination Diet (FFED) | Experimental | Other: Four Food Elimination DietThere 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. |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four Food Elimination DietFood 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. | Other | Four Food Elimination Diet (FFED) |
Primary outcome
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.
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.
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 secondary outcomes
Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)
Time frame: 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
Time to Disease Recurrence as Measured by EST score
Time frame: 4 weeks after food re-introduction
Time to Disease Recurrence as Measured by EST score
Time frame: 2 weeks after food re-introduction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- 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.
Calies Menard-Katcher, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Four Food Elimination Diet in people with Eosinophilic Esophagitis, run by University of Colorado, Denver.
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 7 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: withdrawn, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2023.