The Immune Directed Individualized Elimination Therapy (iDIET) Study

Eosinophilic Esophagitis Clinical Trial

— iDIET  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05543512
• Other study ID #: 22-0500
• Secondary ID: R01DK132001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 14, 2022
• Est. completion date: January 30, 2025

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• EoE
• Eosinophilic Esophagitis
• Esophagitis

Intervention

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.

Locations

Country	Name	City	State
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-treatment peak eosinophil count	Post-treatment peak eosinophil count (measured in eos/hpf)	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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	8 weeks
Secondary	Change in peak eosinophil count	Change in peak eosinophil count from baseline to post-treatment (week 8)	Baseline and Week 8