The Immune Directed Individualized Elimination Therapy (iDIET) Study (iDIET)
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|ClinicalTrials.gov Identifier: NCT05543512|
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2022
Last Update Posted : December 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis EoE||Device: Algorithm to diagnose food allergens Other: Sham diet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Targeted elimination diet therapy versus sham diet elimination therapy|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||An Allergen-specific Immune Signature-directed Diet vs Sham Diet for Treatment of Eosinophilic Esophagitis: A Pilot-feasibility Study|
|Actual Study Start Date :||October 14, 2022|
|Estimated Primary Completion Date :||January 30, 2025|
|Estimated Study Completion Date :||January 30, 2025|
Experimental: Individualized Diet Elimination Therapy
Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks
Device: Algorithm to diagnose food allergens
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.
Placebo Comparator: Sham Diet Elimination Therapy
Subjects in this arm will be assigned a sham diet to follow for 8 weeks
Other: Sham diet
Sham diet developed via selecting a random number of foods from a random list of the potential eliminated foods.
- Post-treatment peak eosinophil count [ Time Frame: 8 weeks ]Post-treatment peak eosinophil count (measured in eos/hpf)
- Dysphagia symptom score [ Time Frame: 8 weeks ]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.
- Endoscopic severity [ Time Frame: 8 weeks ]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.
- Percentage of Histologic Responders [ Time Frame: 8 weeks ]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
- Change in peak eosinophil count [ Time Frame: Baseline and Week 8 ]Change in peak eosinophil count from baseline to post-treatment (week 8)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05543512
|United States, North Carolina|
|The University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Evan S Dellon, MD, MPH||University of North Carolina, Chapel Hill|