Eosinophilic EsophagitisIDiETNCT02722148
Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET)
A study testing Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in people with Eosinophilic Esophagitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a prospective single center clinical trial of allergen-specific immune signature-guided dietary elimination therapy to assess the clinical effectiveness of this technique. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16-80 years old
- Meet one of the following:
- Active EoE as per consensus guidelines OR
- Undergoing upper endoscopy for a clinical suspicion of EoE
- No prior history of dietary elimination therapy
Who cannot join
- Concomitant eosinophilic gastroenteritis
- Any corticosteroid exposure in the 4 weeks prior to their baseline endoscopic exam
- Previous esophageal surgery
- Medical instability that precludes safely performing upper endoscopy
- Inability to read or understand English
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective single center clinical trial of allergen-specific immune signature-guided dietary elimination therapy to assess the clinical effectiveness of this technique.
Read the detailed description
This is a prospective single center clinical trial of allergen-specific immune signature-guided dietary elimination therapy to assess the clinical effectiveness of this technique.
Potential subjects will be approached regarding the study. If eligible and interested, then informed consent will be obtained and they will be enrolled in the study. If the subject as had an esophagogastroduodenoscopy (EGD) at UNC with 3 month since enrollment, clinical biopsies from the EGD show active EoE and the subject continues to meet consensus guidelines for active EoE, and research biopsies were taken during that EGD that can be used for this study, then the subject will complete questionnaires and a blood draw only. The blood draw may be abbreviated if the subject had research blood drawn during the same recent EGD that can be used in this study.
If subjects have not had an EGD with biopsies at UNC within 3 months prior to enrollment, then they will complete questionnaires, a blood draw, and be scheduled to receive a routine care esophagogastroduodenoscopy (EGD) at UNC facilities with clinical and research biopsies. However, in some cases, samples that were obtained prior to this time frame can be used, as long as the samples were obtained when the EoE was active and there were no major changes in clinical status.
During the routine care endoscopy, clinical biopsies will be taken for routine care purposes, and additional research biopsies will be collected for research purposes for diet elimination testing and to be stored for future research studies from the distal, mid, and proximal esophagus. Blood will also be collected during this visit, and questionnaires completed. If research biopsies are unable to be obtained during this EGD the subject will no longer continue in the study and will be considered a screen fail. If pathology from routine care biopsies does not confirm a diagnosis of active EoE, then the subject will no longer continue in the study and will be considered a screen fail. If subjects have had an EGD with clinical and research biopsies within 3 months prior to enrollment, then research biopsies taken during that EGD will be used for this study. As noted above, in some cases, samples that were obtained prior to this time frame can be used, as long as the samples were obtained when the EoE was active and there were no major changes in clinical status.
After completion of the EGD (or collection of EGD records and previous biopsies if an EGD was previously completed), and confirmation of eligibility, subjects will be scheduled for a routine care nutrition counseling appointment. Two weeks prior to the routine care nutrition counseling appointment, subject will begin the dysphagia symptom questionnaire (DSQ). During the routine care nutrition counseling appointment, the subject will receive counseling on which foods to eliminate based on the novel assay results from the research biopsies. Subjects will also receive an allergy skin test during this visit. Results from the allergy skin test will not be used to drive food elimination diet.
Subjects will follow their assigned food elimination diet for 6 weeks. At 6 weeks subjects will be scheduled for a routine care esophagogastroduodenoscopy (EGD) with biopsies for clinical purposes. Two weeks prior to the 6 week EGD subjects will restart the DSQ. Data will be collected from the 6 week EGD but no research specific biopsies will be obtained during that visit. Research specific blood will be taken at this visit. Study participation is complete after completion of the 6 week EGD.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy
- Keywords
- Eosinophilic Esophagitis, Diet Elimination Therapy
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination TherapyDevice
A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Patients | Experimental | All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy Receives: Device: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Histologic Responders
The primary outcome will be histologic response, defined as a post-treatment esophageal eosinophil count of <15 eos/hpf.
Measured: 6 Weeks
Secondary outcomes (3)
Median Peak Esophageal Eosinophil Count
Eosinophil count per High Power Field
Measured: 6 Weeks
Endoscopy Score
Post treatment endoscopic appearance, as measured by a validated endoscopy score - the EoE Endoscopic Reference Score (EREFS). This score measures endoscopic severity with a set of five endoscopic findings (exudates, rings, edema, furrows, and strictures), and ranges from 0-9, with higher scores indicating higher endoscopic severity.
Measured: 6 Weeks
Dysphagia Symptom Score
Post treatment symptoms, as measured by a validated dysphagia symptom score, the EoE Symptom Activity Index (EEsAI). This score ranges from 0-100, with higher scores indicating more severe symptoms. A score of < 20 indicates clinical remission.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start21 Apr 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Evan S Dellon, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722148
- Sponsor's protocol ID
- 15-2719
- Acronym
- IDiET
- Status last verified
- Aug 2018
- First submitted
- 24 Mar 2016
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plans to share data
Publications
Dellon ES, Guo R, McGee SJ, Hamilton DK, Nicolai E, Covington J, Moist SE, Arrington A, Wright BL, Burks AW, Vickery BP, Kulis M. A Novel Allergen-Specific Immune Signature-Directed Approach to Dietary Elimination in Eosinophilic Esophagitis. Clin Transl Gastroenterol. 2019 Dec;10(12):e00099. doi: 10.14309/ctg.0000000000000099.
PubMed 31789931
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET)
- ClinicalTrials.gov ID
- NCT02722148
- Acronym / sponsor ID
- IDiET / 15-2719
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis, Diet Elimination Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Posted 2 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective single center clinical trial of allergen-specific immune signature-guided dietary elimination therapy to assess the clinical effectiveness of this technique.
Detailed description
This is a prospective single center clinical trial of allergen-specific immune signature-guided dietary elimination therapy to assess the clinical effectiveness of this technique.
Potential subjects will be approached regarding the study. If eligible and interested, then informed consent will be obtained and they will be enrolled in the study. If the subject as had an esophagogastroduodenoscopy (EGD) at UNC with 3 month since enrollment, clinical biopsies from the EGD show active EoE and the subject continues to meet consensus guidelines for active EoE, and research biopsies were taken during that EGD that can be used for this study, then the subject will complete questionnaires and a blood draw only. The blood draw may be abbreviated if the subject had research blood drawn during the same recent EGD that can be used in this study.
If subjects have not had an EGD with biopsies at UNC within 3 months prior to enrollment, then they will complete questionnaires, a blood draw, and be scheduled to receive a routine care esophagogastroduodenoscopy (EGD) at UNC facilities with clinical and research biopsies. However, in some cases, samples that were obtained prior to this time frame can be used, as long as the samples were obtained when the EoE was active and there were no major changes in clinical status.
During the routine care endoscopy, clinical biopsies will be taken for routine care purposes, and additional research biopsies will be collected for research purposes for diet elimination testing and to be stored for future research studies from the distal, mid, and proximal esophagus. Blood will also be collected during this visit, and questionnaires completed. If research biopsies are unable to be obtained during this EGD the subject will no longer continue in the study and will be considered a screen fail. If pathology from routine care biopsies does not confirm a diagnosis of active EoE, then the subject will no longer continue in the study and will be considered a screen fail. If subjects have had an EGD with clinical and research biopsies within 3 months prior to enrollment, then research biopsies taken during that EGD will be used for this study. As noted above, in some cases, samples that were obtained prior to this time frame can be used, as long as the samples were obtained when the EoE was active and there were no major changes in clinical status.
After completion of the EGD (or collection of EGD records and previous biopsies if an EGD was previously completed), and confirmation of eligibility, subjects will be scheduled for a routine care nutrition counseling appointment. Two weeks prior to the routine care nutrition counseling appointment, subject will begin the dysphagia symptom questionnaire (DSQ). During the routine care nutrition counseling appointment, the subject will receive counseling on which foods to eliminate based on the novel assay results from the research biopsies. Subjects will also receive an allergy skin test during this visit. Results from the allergy skin test will not be used to drive food elimination diet.
Subjects will follow their assigned food elimination diet for 6 weeks. At 6 weeks subjects will be scheduled for a routine care esophagogastroduodenoscopy (EGD) with biopsies for clinical purposes. Two weeks prior to the 6 week EGD subjects will restart the DSQ. Data will be collected from the 6 week EGD but no research specific biopsies will be obtained during that visit. Research specific blood will be taken at this visit. Study participation is complete after completion of the 6 week EGD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Patients | Experimental | Device: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination TherapyAll enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 16-80 years old
- Meet one of the following:
- No prior history of dietary elimination therapy
Key exclusion criteria (6 listed)
- Concomitant eosinophilic gastroenteritis
- Any corticosteroid exposure in the 4 weeks prior to their baseline endoscopic exam
- Previous esophageal surgery
- Medical instability that precludes safely performing upper endoscopy
- Inability to read or understand English
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 |
|---|---|---|
| Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination TherapyA novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE). | Device | Enrolled Patients |
Primary outcome
Percentage of Histologic Responders
Time frame: 6 Weeks
The primary outcome will be histologic response, defined as a post-treatment esophageal eosinophil count of <15 eos/hpf.
3 secondary outcomes
Median Peak Esophageal Eosinophil Count
Time frame: 6 Weeks
Endoscopy Score
Time frame: 6 Weeks
Dysphagia Symptom Score
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31789931Dellon ES, Guo R, McGee SJ, Hamilton DK, Nicolai E, Covington J, Moist SE, Arrington A, Wright BL, Burks AW, Vickery BP, Kulis M. A Novel Allergen-Specific Immune Signature-Directed Approach to Dietary Elimination in Eosinophilic Esophagitis. Clin Transl Gastroenterol. 2019 Dec;10(12):e00099. doi: 10.14309/ctg.0000000000000099.
- Individual participant dataSharing planned: No. No plans to share data
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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.
Evan S Dellon, MD, MPH principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in people with Eosinophilic Esophagitis, run by University of North Carolina, Chapel Hill at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Histologic Responders (time frame: 6 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 NCT02722148, which also lists 1 linked publication.
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 2 Apr 2019.