The Immune Directed Individualized Elimination Therapy (iDIET) Study

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Sep 14, 2022

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility 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