Diet Changes for Food Allergy

DA
Overseen ByDavid A Hill, MD, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to identify foods causing Eosinophilic esophagitis (EoE), a condition where the esophagus becomes inflamed, making swallowing difficult. Researchers aim to determine if a special blood test can accurately identify problem foods like milk, soy, egg, and wheat, compared to the usual method of endoscopy, which uses a flexible tube to examine the esophagus. Participants will follow an assay-directed diet change, an elimination diet based on test results, to manage their EoE. This trial suits those diagnosed with EoE who have not yet identified their trigger foods and are willing to adjust their diet. As an unphased trial, it offers patients a unique opportunity to contribute to groundbreaking research that could simplify and improve EoE management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on immunomodulatory therapy (like steroids or chemotherapy) for more than 4 weeks, you may not be eligible to participate.

What prior data suggests that this assay-directed diet change is safe for patients with EoE?

Research shows that changing one's diet is a common way to manage Eosinophilic esophagitis (EoE). Studies have found that these changes can help reduce harmful cells in the esophagus and are usually safe for short-term use. However, in a study of 15 adults who tried elimination diets based on allergy tests, 67% did not achieve the desired results. This indicates that while the diet was generally safe, it did not work for everyone.

For those considering this treatment, diet changes are a standard and generally safe way to manage EoE, though results can vary. It is crucial to consult a healthcare provider before making significant dietary changes.12345

Why are researchers excited about this trial?

Researchers are excited about the assay-directed diet change for managing Eosinophilic Esophagitis (EoE) because it offers a personalized approach to treatment. Unlike standard therapies like corticosteroids or proton pump inhibitors, which address symptoms, this method aims to identify and eliminate specific foods causing the allergic reaction. By targeting the root cause, the diet change could lead to more effective and sustainable management of EoE, potentially reducing the need for long-term medication.

What evidence suggests that assay-directed diet changes are effective for EoE?

Research shows that elimination diets can help people with Eosinophilic esophagitis (EoE), a condition where certain foods cause the esophagus to swell. Studies have found that removing four specific foods from the diet can lead to improvement in about 54% of adults with EoE. Another review found that different diet plans often succeed in reducing symptoms and improving the condition. However, skin tests have not been very effective in identifying foods to avoid. In this trial, participants will follow a new test-based approach that aims to better identify problem foods, potentially offering a more effective way to manage EoE through diet.678910

Who Is on the Research Team?

DA

David A Hill, MD, PhD

Principal Investigator

Children's Hospital of Philadelphia, University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals with food allergies, specifically those who may have Eosinophilic esophagitis (EoE). Participants should be willing to undergo diet changes based on assay results and standard-of-care practices. The eligibility criteria details are not fully provided.

Inclusion Criteria

I have been diagnosed with EoE based on a recent biopsy.
Intention to undergo dietary intervention for treatment of EoE
Unknown contribution of one or more of milk, soy, egg, and wheat to their EoE disease state
See 1 more

Exclusion Criteria

Inability to read or understand English
My EoE improved with high-dose acid reflux medication.
I can safely undergo an upper endoscopy with biopsy and have no dietary restrictions.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo blood tests and follow a personalized elimination diet based on T cell assay results and standard-of-care practices

4 weeks

Follow-up

Participants are monitored for changes in symptoms and esophageal eosinophilia through surveys and endoscopy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Assay directed diet change
Trial Overview The study tests if new non-invasive allergen-activated T cell assays can identify foods causing EoE accurately when combined with current standard endoscopies after patients change their diets according to the assay results.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: EoE unknownExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

American Partnership for Eosinophilic Disorders

Collaborator

Food Allergy Fund

Collaborator

Citations

Toward More Efficient Dietary Elimination Therapy for ...In adults, a 4-food elimination diet was found to induce remission in 54% of EoE patients. ... The study comes from an expert group considered to be pioneers in ...
Efficacy of Elimination Diets in Eosinophilic EsophagitisOur systematic review shows that dietary therapy is a valuable treatment option in EoE. Empiric diets can lead to high histologic and clinical remission rates ...
“Efficacy of Elimination Diets in Eosinophilic Esophagitis: A ...The systematic analysis reported a pooled histologic response rate of 43%, a surprising finding, considering that most of these test-directed ...
A Novel Allergen-Specific Immune Signature-Directed ...Selective elimination diet based on skin testing has suboptimal efficacy for adult eosinophilic esophagitis. J Allergy Clin Immunol 2012;130:1200–2. [DOI] ...
Selective elimination diet based on skin testing has ...Selective elimination diet based on skin testing has suboptimal efficacy for adult eosinophilic esophagitis - Journal of Allergy and Clinical Immunology.
Dietary Management of Eosinophilic Esophagitis - PMCIn an adult case series of 15 patients with EoE undergoing elimination diets directed by multimodal allergy testing, 67% failed to achieve either clinical or ...
Study Details | NCT07023380 | EoE Food Test Pilot StudyResponse to research assay-directed diet changes will provide information about the assay's clinical value.
Technical Review on the Management of Eosinophilic ...Multiple dietary strategies may be effective in reducing esophageal eosinophil counts to <15 per high-power field over a short-term treatment period, with ...
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 ...
Nutritional Care of the Patient with Eosinophilic EsophagitisTo do this, dietary elimination is managed with one of three options: elemental formula, empiric dietary elimination, and test- directed dietary modification.
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