NCT05543512

The Immune Directed Individualized Elimination Therapy (iDIET) Study

An Allergen-specific Immune Signature-directed Diet vs Sham Diet for Treatment of Eosinophilic Esophagitis: A Pilot-feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Eosinophilic Esophagitis
• EoE

Interventions

Type	Name	Description
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.
OTHER	Sham diet	Sham diet developed via selecting a random number of foods from a random list of the potential eliminated foods.

Timeline

• Start date: 2022-10-14
• Primary completion: 2025-12-18
• Completion: 2026-03-01
• First posted: 2022-09-16
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study