The Immune Directed Individualized Elimination Therapy (iDIET) Study

Completed · Not applicable · Has a placebo group

Conditions studied: Eosinophilic Esophagitis, EoE

In brief

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

Key facts

Study ID

NCT05543512

Run by

University of North Carolina, Chapel Hill

People needed

56

Starts

2022-10-14

Expected to finish

2025-12-18

Last updated by the study team

2026-05-05

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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).
• 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

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

Where it is running

• The University of North Carolina at Chapel Hill — Chapel Hill, NC 27599-7080, North Carolina, United States

Full record on ClinicalTrials.gov

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