Individualized Elimination Diet for Eosinophilic Esophagitis

(iDIET Trial)

Overseen By Susan Moist, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Blood thinners

Disqualifiers: Eosinophilic gastritis, Esophageal resection, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a specialized diet for people with eosinophilic esophagitis (EoE), a condition where white blood cells accumulate in the esophagus, causing swallowing difficulties and pain. Participants will either follow a personalized diet designed to avoid specific allergens or a sham diet for comparison. The goal is to determine if the personalized diet, known as Immune Directed Individualized Elimination Therapy (iDIET), can more effectively reduce symptoms. Individuals diagnosed with EoE who have not tried or failed a specific diet treatment before might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore new dietary approaches for managing EoE symptoms.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking blood thinners like coumadin, warfarin, and heparin before participating. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What prior data suggests that this dietary elimination treatment is safe for eosinophilic esophagitis?

Research has shown that Immune Directed Individualized Elimination Therapy (iDIET) is generally easy for people to handle. Some studies have found that eliminating certain foods can reduce symptoms in individuals with eosinophilic esophagitis, a condition where allergens inflame the esophagus. Previous research indicates that removing specific allergens from the diet has improved symptoms for many patients. For example, eliminating cow's milk relieved symptoms in about 44–51% of children. Reports of serious side effects from this dietary treatment are rare. Since this approach involves dietary changes rather than medication, the risk of harmful side effects is usually lower. However, following the diet carefully is important to maintain balanced nutrition. Clinical trial participants are typically monitored closely to address any potential issues early. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iDIET approach for eosinophilic esophagitis because it tailors a diet specifically to an individual's immune response to allergens. Unlike standard treatments, which often involve eliminating common food triggers based on trial and error, iDIET uses an allergen-specific immune signature to create a personalized diet plan. This method aims to more precisely identify and eliminate the exact foods triggering an immune response, potentially leading to more effective and faster symptom relief. This personalized approach could revolutionize how dietary management is handled for this condition, offering hope for better outcomes and quality of life for patients.

What evidence suggests that this trial's treatments could be effective for eosinophilic esophagitis?

Research has shown that elimination diets can help treat eosinophilic esophagitis (EoE), a condition where certain white blood cells accumulate in the esophagus, causing inflammation. One study found that patients on diets tailored to their specific allergies experienced a significant drop in white blood cell counts, from 75 to 35, indicating reduced inflammation. Elimination diets achieved a success rate of up to 80.8%, with some specific diets proving even more effective. Additionally, 71% of patients reported symptom improvement, and more than half showed better results in their esophagus during an endoscopy. In this trial, participants will receive either an Individualized Diet Elimination Therapy, tailored based on allergen-specific immune signatures, or a Sham Diet Elimination Therapy. These findings suggest that a personalized elimination diet could effectively manage EoE. ^{5 6 7 8 9}

Who Is on the Research Team?

Evan Dellon, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My biopsy shows I have active Eosinophilic Esophagitis.

I am between 16 and 80 years old.

Exclusion Criteria

Inability to read or understand English

Body mass index (BMI) <17

I have a history of bleeding disorders or esophageal varices.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow an allergen-specific immune signature-directed diet or sham diet for 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Immune Directed Individualized Elimination Therapy (iDIET) Study

Trial Overview 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.

How Is the Trial Designed?

Group I: Individualized Diet Elimination Therapy Experimental Treatment 1 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 Therapy Placebo Group 1 Intervention

Subjects in this arm will be assigned a sham diet to follow for 8 weeks

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6970559/

A Novel Allergen-Specific Immune Signature-Directed ... After treatment, median peak eosinophil counts decreased from 75 to 35 (P = 0.007); there were 4 histologic responders (21%). The EoE Endoscopic Reference Score ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1542356523000782

Efficacy of Elimination Diets in Eosinophilic Esophagitis The overall rate of clinical response was 80.8% (95% CI, 72.3%–88.2%), with response rates of 92.8% (95% CI, 81.2%–99.6%) for SFED, 74.1% (95% CI, 49.8%–92.6%) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4102669/

Dietary Elimination Therapy is an Effective Option for ... Symptoms improved in 71% (68% in targeted, 78% in SFED) and endoscopic appearance improved in 54% (53% in targeted, 56% in SFED). After dietary therapy, the ...

4. mdpi.com mdpi.com/2072-6643/16/14/2231

Efficacy of Dietary Therapy for Eosinophilic Esophagitis in ... The effectiveness of dietary interventions was slightly superior for most studies conducted in North America compared to those carried out in Europe, including ...

5. jacionline.org jacionline.org/article/S0091-6749(14)01011-2/fulltext

Four-food group elimination diet for adult eosinophilic ... An FFGED achieved clinicopathologic remission in 54% of adult patients with EoE. An SFGED was effective in almost a third of FFGED nonresponders.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02722148?tab=results

Application of a Novel Allergen-Specific Immune Signature ... A Novel Allergen-Specific Immune Signature-Directed Approach to Dietary Elimination in Eosinophilic Esophagitis. Clin Transl Gastroenterol. 2019 Dec;10(12): ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8812465/

Diet Therapy in Eosinophilic Esophagitis. Focus on a ... The elimination of cow's milk (1-FED) demonstrated disease-remission rates of 44–51% in pediatric patients (27). In a recent systematic review with meta- ...

8. clinicaltrial.be clinicaltrial.be/en/details/175497?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

The Immune Directed Individualized Elimination Therapy (i... Secondary outcomes. 1. Dysphagia symptom score. Dysphagia symptom score, as measured by the validated Eosinophilic Esophagitis Activity Index ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1542356523001866

Development of a Practical Guide to Implement and ... This review aims to summarize evidence in support of dietary therapy in eosinophilic esophagitis while providing guidance on initiation and implementation of ...