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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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 moreTrial 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
1,561 Previous Clinical Trials
4,298,681 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
1,160 Patients Enrolled for Eosinophilic Esophagitis
Mayo ClinicOTHER
3,351 Previous Clinical Trials
3,060,857 Total Patients Enrolled
25 Trials studying Eosinophilic Esophagitis
1,391 Patients Enrolled for Eosinophilic Esophagitis
National Institutes of Health (NIH)NIH
2,823 Previous Clinical Trials
8,162,814 Total Patients Enrolled
8 Trials studying Eosinophilic Esophagitis
2,548 Patients Enrolled for Eosinophilic Esophagitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,008 Total Patients Enrolled
13 Trials studying Eosinophilic Esophagitis
3,240 Patients Enrolled for Eosinophilic Esophagitis
Evan S Dellon, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
6 Previous Clinical Trials
1,074 Total Patients Enrolled
6 Trials studying Eosinophilic Esophagitis
1,074 Patients Enrolled for Eosinophilic Esophagitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My biopsy shows I have active Eosinophilic Esophagitis.I am between 16 and 80 years old.I haven't tried or failed a special diet for my condition.I have a history of bleeding disorders or esophageal varices.I am too unwell for a safe upper endoscopy procedure.I have had surgery to remove part of my esophagus.I have been diagnosed with EoE according to standard guidelines.I haven't taken any corticosteroids in the last 4 weeks.I have been diagnosed with eosinophilic gastritis or enteritis.I am currently using blood thinners but can stop them if needed.I haven't tried or failed a special diet to treat my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Individualized Diet Elimination Therapy
- Group 2: Sham Diet Elimination Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.