The Immune Directed Individualized Elimination Therapy (iDIET) Study

NCT05543512 | Completed FDA Device

• 2 other identifiers: 22-0500R01DK132001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

EoE; Eosinophilic Esophagitis

Keywords

EoE; Eosinophilic Esophagitis; Diet Therapy

Outcome Measures

Primary Outcomes (1)

• Post-treatment peak eosinophil count

  Post-treatment peak eosinophil count (measured in eos/hpf)

  8 weeks

Secondary Outcomes (3)

• Dysphagia symptom score

  8 weeks

• Endoscopic severity

  8 weeks

• Percentage of Histologic Responders

  8 weeks

Study Arms (2)

Individualized Diet Elimination Therapy

EXPERIMENTAL

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

Sham Diet Elimination Therapy

PLACEBO COMPARATOR

Subjects in this arm will be assigned a sham diet to follow for 8 weeks

Other: Sham diet

Interventions

Sham diet OTHER

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

Sham Diet Elimination Therapy

Algorithm to diagnose food allergens DEVICE

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.

Individualized Diet Elimination Therapy

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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
• Inability to read or understand English
• Pregnancy or breastfeeding
• Body mass index (BMI) \<17

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Mayo Clinic: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, NC 27599-7080, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Evan S Dellon, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Targeted elimination diet therapy versus sham diet elimination therapy

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: October 14, 2022
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)