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The Immune Directed Individualized Elimination Therapy (iDIET) Study

NCT05543512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-05-05

No results posted yet for this study

Summary

This is a randomized, double blind, sham-controlled, pilot/feasibility trial of individualized dietary elimination treatment.

Conditions

  • Eosinophilic Esophagitis
  • EoE

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Mayo Clinic

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Evan S Dellon, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2025-12-18
Completion
2025-12-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543512 on ClinicalTrials.gov