What side effects are associated with this type of intervention?

The most common side effects of dietary modifications for treating Eosinophilic Esophagitis (EoE), such as the Dairy Elimination Diet (DED) and Dairy Elimination plus Food Additive Elimination (FREE), include nutritional deficiencies due to the exclusion of major food groups, which may require supplementation or careful dietary planning. Additionally, these restrictive diets can have social and psychological impacts, such as increased stress or anxiety related to food choices and social eating situations. Non-compliance is also a potential issue, as maintaining strict dietary restrictions can be challenging over time.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Eosinophilic Esophagitis (EoE) that focus on dietary modifications like Dairy Elimination Diet (DED) and Dairy Elimination plus Food Additive Elimination (FREE). However, dietary management remains a cornerstone of EoE treatment, with elimination diets being commonly recommended to reduce exposure to potential allergens and irritants. These dietary approaches aim to alleviate symptoms and reduce esophageal inflammation by removing specific food triggers.

What other types of research exist?

Promising novel alternatives to Dairy Elimination Diet (DED) and Dairy Elimination plus Food Additive Elimination (FREE) for Eosinophilic Esophagitis (EoE) patients include oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and epicutaneous immunotherapy (EPIT). These therapies aim to desensitize patients to specific allergens, potentially reducing the severity of EoE symptoms. Additionally, peptide immunotherapy and lysosome-associated membrane protein (LAMP) DNA vaccines are emerging treatments under investigation that may offer new avenues for managing EoE in the future.

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Dietary Therapy

Dietary Approaches for Eosinophilic Esophagitis (FREE Trial)

N/A

Waitlist Available

Led By James P Franciosi, MD

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4, 8, and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two diets for children with eosinophilic esophagitis. One diet removes dairy, and the other removes both dairy and food additives. The goal is to see if cutting out these foods can reduce inflammation and improve symptoms.

Who is the study for?

This trial is for children and teens aged 2 to under 18 with Eosinophilic Esophagitis, who can follow the diet plan and survey schedule. They must have internet access, no severe allergies or GI conditions like celiac disease, haven't had upper GI surgery, aren't on certain medications recently (like PPIs), and haven't tried a dairy-free diet for EoE before.

What is being tested?

The study compares two diets in treating pediatric Eosinophilic Esophagitis: one group will avoid only dairy (DED), while the other will eliminate both dairy and food additives (FREE). It's a head-to-head test to see which diet works better.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include nutritional deficiencies or reactions related to dietary adjustments. Specific side effects are not listed but monitoring overall health is important.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4, 8, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4, 8, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4, 8, and 12 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

Eosinophil

Secondary study objectives

Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)

Other study objectives

Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS)

Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS): Parent Report

Pediatric Quality of Life Inventory: Eosinophilic Esophagitis Module (PedsQL-EoE)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: DEDActive Control1 Intervention

Diet eliminating dairy

Group II: FREEActive Control1 Intervention

Diet eliminating dairy and food additives

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Eosinophilic Esophagitis (EoE) include dietary modifications, proton pump inhibitors (PPIs), and topical corticosteroids. Dietary modifications, such as the Dairy Elimination Diet (DED) and Dairy Elimination plus Food Additive Elimination (FREE), work by removing potential allergens and irritants from the diet that may trigger eosinophilic inflammation in the esophagus. This approach aims to reduce the immune response and inflammation, thereby alleviating symptoms like dysphagia and food impaction. For EoE patients, these dietary changes are crucial as they target the root cause of the inflammation, potentially leading to long-term remission and improved quality of life.