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The Immune Directed Individualized Elimination Therapy (iDIET) Study (iDIET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05543512
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2022
Last Update Posted : December 1, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis EoE Device: Algorithm to diagnose food allergens Other: Sham diet Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Targeted elimination diet therapy versus sham diet elimination therapy
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Blinded
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Post-treatment peak eosinophil count [ Time Frame: 8 weeks ]
    Post-treatment peak eosinophil count (measured in eos/hpf)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Change in peak eosinophil count [ Time Frame: Baseline and Week 8 ]
    Change in peak eosinophil count from baseline to post-treatment (week 8)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Investigators
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Principal Investigator: Evan S Dellon, MD, MPH University of North Carolina, Chapel Hill
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT05543512    
Other Study ID Numbers: 22-0500
R01DK132001 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of North Carolina, Chapel Hill:
EoE
Eosinophilic Esophagitis
Diet Therapy
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases