36 Participants NeededMy employer runs this trial

Partial Enteral Nutrition for Eosinophilic Esophagitis

DG
Overseen ByDanny Gagucas
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 dietary treatment for individuals with Eosinophilic Esophagitis (EoE), a condition that makes swallowing difficult and can cause chest pain. Researchers aim to determine if a combination of partial enteral nutrition (a special liquid diet) and eliminating dairy can better manage EoE. The study also examines how this diet affects the immune system and gut health. It is suitable for children and young adults up to 21 years old who experience ongoing symptoms like trouble swallowing, heartburn, or stomach pain and are planning to undergo a scope test to check their esophagus. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance dietary treatments for EoE.

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

The trial requires that you have not taken proton pump inhibitors in the past month, but it doesn't specify about other medications. It's best to discuss your current medications with the trial team.

What prior data suggests that this dietary therapy is safe for EoE patients?

Research has shown that elimination diets, like those used for Eosinophilic Esophagitis (EoE), are generally safe. These diets work by removing certain foods that might trigger symptoms. For example, one study found that eliminating cow's milk led to a 90.8% remission rate in children with EoE, suggesting these dietary changes are well-tolerated.

Another study on a dairy-free diet showed varying success rates based on age, with 59.3% of young children and up to 67.5% of older kids achieving remission. These findings indicate that the diet is effective and manageable for most patients.

Evidence also supports partial enteral nutrition (PEN), which involves replacing some meals with a special formula, as a way to improve remission rates in EoE patients. This method is considered a safe addition to dietary management.

In summary, both removing dairy and using PEN have shown to be well-tolerated by patients with EoE, with a low risk of side effects.12345

Why are researchers excited about this trial?

Unlike the standard treatments for eosinophilic esophagitis (EoE), which often involve medications like steroids or complete elimination diets, this new approach focuses on a partial enteral nutrition (PEN) diet combined with dairy elimination. Researchers are excited about this method because it aims to ease symptoms by modifying the diet, potentially reducing the need for medication and making it easier for patients to manage their condition. The combination of a dairy-free diet with partial enteral nutrition offers a unique way to control inflammation and improve symptoms through dietary changes rather than relying solely on drugs or strict elimination diets. This could lead to a more sustainable and less restrictive way for patients to manage EoE.

What evidence suggests that Partial Enteral Nutrition with Dairy Elimination might be an effective treatment for Eosinophilic Esophagitis?

Research has shown that removing cow's milk from the diet can relieve symptoms in 50% to 65% of children with Eosinophilic Esophagitis (EoE). One study found a 43% symptom relief rate with a similar diet that excludes two specific foods. In this trial, participants will divide into groups to test these approaches. One group will follow a dairy-free diet, while another will follow a dairy-free diet combined with partial enteral nutrition (PEN), which involves replacing part of the diet with a special liquid nutrition formula. These methods aim to manage EoE symptoms by altering children's diets.12367

Who Is on the Research Team?

MP

Michael Pickens, DO

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children and young adults ages 1 to 21 who have ongoing symptoms like trouble swallowing, pain when swallowing, vomiting, heartburn, stomach pain, weight loss, or picky eating and are seeing a GI doctor for an endoscopy.

Inclusion Criteria

I am between 1 and 21 years old with chronic digestive symptoms and planning to have an EGD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo partial enteral nutrition with dairy elimination to assess remission rates and other health metrics

3 months
Baseline, 2 weeks, and 3 months visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Partial Enteral Nutrition with Dairy Elimination

Trial Overview

The study compares two diets for treating Eosinophilic Esophagitis: one group gets partial liquid nutrition plus avoids dairy; the other group avoids dairy only. The goal is to see which diet helps more with remission and how it affects the body.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Dairy free + Partial Enteral Nutrition (PEN) dietExperimental Treatment1 Intervention
Group II: Dairy FreeExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kate Farms Inc

Lead Sponsor

Trials
1
Recruited
60+

Seattle Children's Hospital

Collaborator

Trials
319
Recruited
5,232,000+

Citations

Trial of Partial Enteral Nutrition With Dairy Free Diet ... - MedPath

The study proposes using partial enteral nutrition (PEN) to improve remission rates in EoE patients and investigate the mechanism by which these ...

Dietary Management of Eosinophilic Esophagitis - PMC - NIH

This initial elimination diet achieved remission in 43% of children and adults in the study. Patients who did not respond to this two-food elimination diet ...

Single‐food elimination of cow's milk as a treatment for ...

The evidence demonstrated that CME was effective at achieving histologic remission of disease in 50%–65% of children.

Dietary Management of Eosinophilic Esophagitis

The unexpected low effectiveness of the 4FED and 6FED in this study could be caused by inadequate selection of candidates (enrolling not sufficiently motivated ...

Life with EoE (Eosinophilic Esophagitis) Research Study ...

Throughout this report, data presented will focus on the following key findings in seven areas: diagnosis, symptoms, medical care, treatments, disease ...

A Food Additive Removal Diet for Pediatric Eosinophilic ...

Given that EoE is thought to be an allergen driven disease, elimination diets are considered logical and safe first-line treatment options. Elimination diets ...

Dietary Therapy and Nutrition Management of Eosinophilic ...

An ED may be a useful starting point for motivated patients with EoE to gain remission, and may be followed by the reintroduction of foods. ED therapy may ...