Eosinophilic EsophagitisiDIETNCT05543512
The Immune Directed Individualized Elimination Therapy (iDIET) Study
A study testing Algorithm to diagnose food allergens in people with Eosinophilic Esophagitis and EoE, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a randomized, double blind, sham-controlled, pilot/feasibility trial of individualized dietary elimination treatment. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Eosinophilic Esophagitis, EoE
- What is being tested?
- Algorithm to diagnose food allergens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to 18 Dec 2025
- 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
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age: 16 - 80 years
- Diagnosis of EoE as per consensus guidelines
- No prior treatment with, or documented failure of, dietary elimination therapy. Failure is defined as =>15 eos/hpf after a course of the six-food elimination diet (SFED).
- On stable diet for 4 weeks prior to screening endoscopy and agree to maintain throughout course of participation. Foods eliminated for allergic or other reactions are not exclusionary and may continue to be avoided throughout participation in the study regardless of food trigger results.
- In addition to meeting the above criteria, to be eligible for randomization an individual must meet all of the following criteria:
- Active EoE (=>15 eos/hpf) based on clinical biopsies taken during baseline endoscopy
- Must have at least one positive food on the IgG4 or T cell stimulation assay
Who cannot join
- Concomitant eosinophilic gastritis and/or enteritis, confirmed with a prior clinicohistologic diagnosis
- Use of systemic corticosteroids within 4 weeks of the baseline/qualifying endoscopic exam
- Previous esophageal resection
- History of bleeding disorder or esophageal varices
- Current use of blood thinners such as coumadin, warfarin, heparin, and/or novel anticoagulant agents (requires discontinuation of medication within an appropriate time frame for that specific agent and in accordance with standard clinical practice)
- Medical instability that precludes safely performing upper endoscopy
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- Inability to read or understand English
- Pregnancy or breastfeeding
- Body mass index (BMI) <17
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: An Allergen-specific Immune Signature-directed Diet vs Sham Diet for Treatment of Eosinophilic Esophagitis: A Pilot-feasibility Study
This is a randomized, double blind, sham-controlled, pilot/feasibility trial of individualized dietary elimination treatment.
Read the detailed description
Participants will be randomized in a 1:1 fashion to follow an allergen-specific immune signature-directed diet or sham diet during the 8-week treatment period. Blood and biopsies specific to this study will be collected during a baseline endoscopy completed as part of their routine clinical care. Samples will be immediately transported to a lab in which T-cell and immunoglobulin G4 (IgG4) signatures will be analyzed for the full 18 food panel. If randomized to the active intervention, then participants in a blinded fashion will be assigned a diet that removes the foods for which they had a positive threshold result on either the T-cell or IgG4 assay. If randomized to the sham diet, then participants will be provided a sham diet. Sham diets will be developed via selecting a random number of foods from a random list of the potential eliminated foods. The participant, investigators, clinical research coordinators, and study dietician will be blinded to the results of laboratory analysis during the course of the study. The lab, study monitor, or other designee not otherwise involved in the study will be unblinded.
Upon assignment of their diet intervention, participants will meet with a study dietician to discuss their baseline food consumption and assigned diet intervention. After 4 and 8 weeks of diet intervention, they will check-in with the study dietician. In addition, they will monitor their food intake for compliance. At the end of the 8-week treatment period, participants will return for an endoscopy with biopsies and blood draw. Upon completion of the 8-week endoscopy, participation in this study is complete and participants will return to routine care of their condition which may include dietary re-introduction if clinically indicated after completion of the iDIET study.
The primary hypothesis is that participants treated with the immune-signature diet will have significantly lower post-treatment eosinophil counts and dysphagia symptom scores than participants treated with sham diet.
- Conditions
- Eosinophilic Esophagitis, EoE
- Being tested
- Algorithm to diagnose food allergens, Sham diet
- Keywords
- EoE, Eosinophilic Esophagitis, Diet 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.
Algorithm to diagnose food allergensDevice
An algorithm to diagnose food allergens that will drive diet intervention assignment for those in the active arm. Subjects randomized to this group will receive a diet assignment based on results of the algorithm.
Sham dietOther
Sham diet developed via selecting a random number of foods from a random list of the potential eliminated foods.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Diet Elimination Therapy | Experimental | Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks Receives: Device: Algorithm to diagnose food allergens |
| Sham Diet Elimination Therapy | Placebo comparator | Subjects in this arm will be assigned a sham diet to follow for 8 weeks Receives: Other: Sham diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment Peak Eosinophil Count
Post-treatment peak eosinophil count (measured in eos/hpf)
Measured: 8 weeks
Secondary outcomes (3)
Dysphagia Symptom Score
Dysphagia symptom score, as measured by the validated Eosinophilic Esophagitis Activity Index (EEsAI) instrument This score ranges from 0-100, with higher scores indicating more severe symptoms. A score of < 20 indicates clinical remission.
Measured: 8 weeks
Endoscopic Severity
Endoscopic severity will be assessed using the validated 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: 8 weeks
Percentage of Histologic Responders
Histologic response is defined as an esophageal eosinophil count of <15 eos/hpf, a threshold previously determined to be optimal for response assessments in EoE studies
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start24 Oct 2022
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
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.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Targeted elimination diet therapy versus sham diet elimination therapy
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 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), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Evan S Dellon, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543512
- Sponsor's protocol ID
- 22-0500
- Other IDs
- R01DK132001
- Acronym
- iDIET
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2022
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Allergen-specific Immune Signature-directed Diet vs Sham Diet for Treatment of Eosinophilic Esophagitis: A Pilot-feasibility Study
- ClinicalTrials.gov ID
- NCT05543512
- Acronym / sponsor ID
- iDIET / 22-0500
- Conditions
- Eosinophilic Esophagitis, EoE
- Keywords
- EoE, Eosinophilic Esophagitis, Diet Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mayo Clinic
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Posted 28 Aug 2026
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 randomized, double blind, sham-controlled, pilot/feasibility trial of individualized dietary elimination treatment.
Detailed description
Participants will be randomized in a 1:1 fashion to follow an allergen-specific immune signature-directed diet or sham diet during the 8-week treatment period. Blood and biopsies specific to this study will be collected during a baseline endoscopy completed as part of their routine clinical care. Samples will be immediately transported to a lab in which T-cell and immunoglobulin G4 (IgG4) signatures will be analyzed for the full 18 food panel. If randomized to the active intervention, then participants in a blinded fashion will be assigned a diet that removes the foods for which they had a positive threshold result on either the T-cell or IgG4 assay. If randomized to the sham diet, then participants will be provided a sham diet. Sham diets will be developed via selecting a random number of foods from a random list of the potential eliminated foods. The participant, investigators, clinical research coordinators, and study dietician will be blinded to the results of laboratory analysis during the course of the study. The lab, study monitor, or other designee not otherwise involved in the study will be unblinded.
Upon assignment of their diet intervention, participants will meet with a study dietician to discuss their baseline food consumption and assigned diet intervention. After 4 and 8 weeks of diet intervention, they will check-in with the study dietician. In addition, they will monitor their food intake for compliance. At the end of the 8-week treatment period, participants will return for an endoscopy with biopsies and blood draw. Upon completion of the 8-week endoscopy, participation in this study is complete and participants will return to routine care of their condition which may include dietary re-introduction if clinically indicated after completion of the iDIET study.
The primary hypothesis is that participants treated with the immune-signature diet will have significantly lower post-treatment eosinophil counts and dysphagia symptom scores than participants treated with sham diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Targeted elimination diet therapy versus sham diet elimination therapy
| Arm | Type | Receives |
|---|---|---|
| Individualized Diet Elimination Therapy | Experimental | Device: Algorithm to diagnose food allergensSubjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks |
| Sham Diet Elimination Therapy | Placebo comparator | Other: Sham dietSubjects in this arm will be assigned a sham diet to follow for 8 weeks |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age: 16 - 80 years
- Diagnosis of EoE as per consensus guidelines
- No prior treatment with, or documented failure of, dietary elimination therapy. Failure is defined as =>15 eos/hpf after a course of the six-food elimination diet (SFED).
- On stable diet for 4 weeks prior to screening endoscopy and agree to maintain throughout course of participation. Foods eliminated for allergic or other reactions are not exclusionary and may continue to be avoided throughout participation in the study regardless of food trigger results.
Key exclusion criteria (9 listed)
- Concomitant eosinophilic gastritis and/or enteritis, confirmed with a prior clinicohistologic diagnosis
- Use of systemic corticosteroids within 4 weeks of the baseline/qualifying endoscopic exam
- Previous esophageal resection
- History of bleeding disorder or esophageal varices
- Current use of blood thinners such as coumadin, warfarin, heparin, and/or novel anticoagulant agents (requires discontinuation of medication within an appropriate time frame for that specific agent and in accordance with standard clinical practice)
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 |
|---|---|---|
| Algorithm to diagnose food allergensAn algorithm to diagnose food allergens that will drive diet intervention assignment for those in the active arm. Subjects randomized to this group will receive a diet assignment based on results of the algorithm. | Device | Individualized Diet Elimination Therapy |
| Sham dietSham diet developed via selecting a random number of foods from a random list of the potential eliminated foods. | Other | Sham Diet Elimination Therapy |
Primary outcome
Post-treatment Peak Eosinophil Count
Time frame: 8 weeks
Post-treatment peak eosinophil count (measured in eos/hpf)
3 secondary outcomes
Dysphagia Symptom Score
Time frame: 8 weeks
Endoscopic Severity
Time frame: 8 weeks
Percentage of Histologic Responders
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Eosinophilic Esophagitis
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A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
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Natural History and Genetics of Food Allergy and Related Conditions
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EoE, Eosinophilic Esophagitis
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
University of North Carolina, 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 Algorithm to diagnose food allergens in people with Eosinophilic Esophagitis and EoE, 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 8 inclusion and 9 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 28 Aug 2026. 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. Some participants in this study may receive a placebo. 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 28 Aug 2026). 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?
Post-treatment Peak Eosinophil Count (time frame: 8 weeks). 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 28 Aug 2026.