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Recruiting NCT07234825

Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis

No phase Interventional Eosinophilic Esophagitis (EoE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial enteral nutrition (PEN) with dairy elimination, Dairy elimination alone.
Who it may be relevant to
Registry conditions: Eosinophilic Esophagitis (EoE). Basic parameters: 1 year — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis Induction of Remission

Overview

This study aims to introduce a new dietary therapy for Eosinophilic Esophagitis (EoE) patients by using partial enteral nutrition (PEN) to enhance remission rates and explore how this approach affects immune function, gut microbiota, and environmental toxin exposures.

Detailed description

The purpose of this research project is to offer patients diagnosed with Eosinophilic Esophagitis (EoE) a novel dietary therapy approach which models that of evidence-based dietary therapy used in Crohn's disease and the principles of dietary antigen elimination currently successfully implemented in EoE patients. The study proposes using partial enteral nutrition (PEN) to improve remission rates in EoE patients and investigate the mechanism by which these effects immune dysregulation, microbiota shifts, and through assessment of changes in environmental toxin exposure.

Objectives 1: Determine clinical and endoscopic remission rates, adherence, nutrition, and anthropometric measures in EoE patients prior to and three months after PEN with dairy elimination.

Objectives 2: Investigate immune profiles in EoE patients prior to and three months after PEN with dairy elimination.

Objectives 3: Investigate the microbiota in EoE patients prior to and three months after PEN with dairy elimination.

Objectives 4: Investigate environmental contaminants prior to and three months after PEN with dairy elimination.

It is hypothesized favorable shifts in the microbiota, immune system, and environmental contaminants will be present following three months of PEN in the EoE patient population.

Interventions

  • Other Partial enteral nutrition (PEN) with dairy elimination
    Patients in the PEN with dairy elimination group will receive 50% calories from Kate Farms Standard 1.2 formula and 50% dairy free regular diet.
  • Other Dairy elimination alone
    Participants in this group will be on a dairy-free regular diet alone.

Primary outcome measures

  • Feasibility of PEN assessed by 3-day diet record [Time frame: 3 months]
  • Tolerability of PEN in EoE patients will be assessed by stool quality evaluated using the Bristol Stool Chart. [Time frame: 3 months]
  • Clinical and endoscopic remission rates assessed by mucosal eosinophilia and Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) from GI tissue biopsies [Time frame: 3 months]
  • Immune profiles assessed by blood markers [Time frame: 3 months]
  • Microbiota shifts in EoE patients [Time frame: 3 months]
  • Environmental contaminants assessed by blood serum levels [Time frame: 3 months]
Secondary outcome measures (2)
  • Nutritional status assessed by 3-day diet record and blood collection [Time frame: 3 months]
  • Growth and development assessed by anthropometric measure [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Pediatric patients 1 year to 21 of age presenting with chronic symptoms of dysphagia, odynophagia, vomiting or heartburn, chronic abdominal pain, weight loss, picky eating, to outpatient gastroenterology clinic and are planning to undergo EGD for evaluation.

Exclusion criteria

  • Non-English-Speaking Subjects, adults unable to consent, wards of the state, pregnant women, and prisoners will be excluded from the study.
  • Patients with autoimmune conditions such as inflammatory bowel disease. Patients with prior esophageal or intestinal surgeries.
  • Patients with history of eating disorders or ARFID.
  • Patients with fistulizing or fibrotic disease on baseline EGD.
  • Patients who have received proton pump inhibitory therapy in the past month.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Seattle Children's Hospital — Seattle

Identifiers

NCT: NCT07234825 · Seattle2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗