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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
Active EoE (>15 eos/hpf) based on clinical biopsies taken during baseline endoscopy
Diagnosis of EoE as per consensus guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

iDIET Trial 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.Check my eligibility
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.See study design
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.

iDIET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My biopsy shows I have active Eosinophilic Esophagitis.
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I have been diagnosed with EoE according to standard guidelines.
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I am between 16 and 80 years old.
Select...
I haven't tried or failed a special diet to treat my condition.

iDIET Trial 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

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

iDIET 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
1,504 Previous Clinical Trials
4,187,562 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
1,160 Patients Enrolled for Eosinophilic Esophagitis
Mayo ClinicOTHER
3,206 Previous Clinical Trials
3,766,983 Total Patients Enrolled
25 Trials studying Eosinophilic Esophagitis
1,391 Patients Enrolled for Eosinophilic Esophagitis
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,479 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I become involved in this clinical research?

"Eligible patients for this clinical trial must have eosinophilic esophagitis, and their age should be between 16 to 80 years old. A total of 100 people are expected to sign up."

Answered by AI

Is access to this trial available for participants at the present time?

"Clinicaltrials.gov reveals that recruitment for this medical investigation is currently on pause, which began when the trial was first published on October 14th 2022 and last edited November 28th 2022. Fortunately, there are 53 other clinical trials actively seeking enrolment right now."

Answered by AI

Are younger people within the qualifying age range for this investigation?

"To be considered eligible for this trial, applicants must lie between the ages of 16 and 80. Furthermore, there are 26 studies dedicated to minors (under 18) and 37 for seniors (over 65 years old)."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The Immune Directed Individualized Elimination Therapy (iDIET) Study
2022. "The Immune Directed Individualized Elimination Therapy (iDIET) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05543512.
All > Eosinophilic Esophagitis
~33 spots leftby Jan 2025
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