Individualized Elimination Diet for Eosinophilic Esophagitis

(iDIET Trial)

Overseen By Susan Moist, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Blood thinners

Disqualifiers: Eosinophilic gastritis, Esophageal resection, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Evan Dellon, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals aged 16-80 with active Eosinophilic Esophagitis (EoE), evidenced by biopsies, who haven't had success with or tried dietary elimination therapy. Participants must have a stable diet for the past month and at least one positive food allergen test result. Exclusions include use of blood thinners, medical conditions preventing safe endoscopy, inability to understand English, pregnancy/breastfeeding, very low body weight (BMI <17), other eosinophilic disorders, recent steroid use, esophageal surgery history or bleeding disorders.

Inclusion Criteria

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

My biopsy shows I have active Eosinophilic Esophagitis.

I am between 16 and 80 years old.

Exclusion Criteria

Inability to read or understand English

Body mass index (BMI) <17

I have a history of bleeding disorders or esophageal varices.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow an allergen-specific immune signature-directed diet or sham diet for 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Immune Directed Individualized Elimination Therapy (iDIET) Study

Trial Overview The iDIET study tests an individualized dietary elimination treatment based on diagnosing specific food allergens versus a sham diet. It's randomized and double-blind meaning participants are randomly assigned to real or placebo treatments without knowing which they receive.

Participant Groups

Group I: Individualized Diet Elimination Therapy Experimental Treatment 1 Intervention

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

Group II: Sham Diet Elimination Therapy Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+