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Behavioural Intervention

Individualized Elimination Diet for Eosinophilic Esophagitis (iDIET Trial)

N/A
Waitlist Available
Led By Evan S Dellon, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

Summary

This trial is testing a new dietary treatment for an unspecified condition. The treatment will be given to some participants randomly, and others will be given a sham (fake) treatment. The trial is small and is only meant to test whether the treatment is feasible.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may be less severe but could include potential nutritional deficiencies or gastrointestinal discomfort depending on the foods eliminated as part of the treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-treatment peak eosinophil count
Secondary study objectives
Change in peak eosinophil count
Deglutition Disorders
Endoscopic severity
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Individualized Diet Elimination TherapyExperimental Treatment1 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 TherapyPlacebo Group1 Intervention
Subjects in this arm will be assigned a sham diet to follow for 8 weeks

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,555 Previous Clinical Trials
4,298,333 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
1,160 Patients Enrolled for Eosinophilic Esophagitis
Mayo ClinicOTHER
3,339 Previous Clinical Trials
3,062,045 Total Patients Enrolled
25 Trials studying Eosinophilic Esophagitis
1,391 Patients Enrolled for Eosinophilic Esophagitis
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,511 Total Patients Enrolled
8 Trials studying Eosinophilic Esophagitis
2,248 Patients Enrolled for Eosinophilic Esophagitis

Media Library

Immune Directed Individualized Elimination Therapy (iDIET) Study (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05543512 — N/A
Eosinophilic Esophagitis Research Study Groups: Individualized Diet Elimination Therapy, Sham Diet Elimination Therapy
Eosinophilic Esophagitis Clinical Trial 2023: Immune Directed Individualized Elimination Therapy (iDIET) Study Highlights & Side Effects. Trial Name: NCT05543512 — N/A
Immune Directed Individualized Elimination Therapy (iDIET) Study (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543512 — N/A
~7 spots leftby Jan 2025
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