The Immune Directed Individualized Elimination Therapy (iDIET) Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05543512
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of North Carolina, Chapel Hill
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Evan S Dellon, MD, MPH
Principal Investigator Affiliation	University of North Carolina, Chapel Hill
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis, EoE

Additional Details

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.

Arms & Interventions

Arms

Experimental: Individualized Diet Elimination Therapy

Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks

Placebo Comparator: Sham Diet Elimination Therapy

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chapel Hill, North Carolina

Status

Address

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Clinical Trial Finder