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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Eosinophilic Esophagitis (EoE)
• Intervention / Treatment: Other: Dairy elimination alone; Other: Partial enteral nutrition (PEN) with dairy elimination

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danny Gagucas; Phone Number: 206-987-1062; Email: Danny.Gagucas@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Contact: Elizabeth Reznikov, DO, PhD; Phone Number: 206-987-1062; Email: Elizabeth.Reznikov@seattlechildrens.org
      • Sub-Investigator: Elizabeth Reznikov, DO, PhD
      • Principal Investigator: Michael Pickens, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 12 participants will be control subjects without diagnosis of EoE
Experimental: Dairy Free; 12 subjects will be enrolled in the dairy free diet group.	Other: Dairy elimination alone; Participants in this group will be on a dairy-free regular diet alone.
Experimental: Dairy free + Partial Enteral Nutrition (PEN) diet; 12 subjects will be enrolled in the diary free and 50% PEN diet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of PEN assessed by 3-day diet record	Feasibility and adherence of PEN in EoE patients will be evaluated using 3-day diet records collected at 2 weeks post initiation of the study and at 3 months.	3 months
Tolerability of PEN in EoE patients will be assessed by stool quality evaluated using the Bristol Stool Chart.	Bristol stool chart will be used to assess stool quality at 2 weeks and at month 3.	3 months
Clinical and endoscopic remission rates assessed by mucosal eosinophilia and Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) from GI tissue biopsies	For baseline and three-month tissue collection, GI tissue biopsies will be obtained at the time of clinical endoscopy assess mucosal eosinophilia and EoE-HSS.	3 months
Immune profiles assessed by blood markers	Immune profiles in EoE patients will be assessed by blood markers using CBC with differential, comprehensive metabolic panel, C-Reactive Protein, and Erythrocyte Sedimentation Rate before and after PEN and dairy elimination.	3 months
Microbiota shifts in EoE patients	Microbiota shifts will be assessed from stool metabolomics, urine metabolomics, oral swab microbiome, and esophageal brushing of EoE before and after PEN and dairy free diets.	3 months
Environmental contaminants assessed by blood serum levels	Environmental contaminants assessed by CBC with differential before and after PEN with dairy elimination.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status assessed by 3-day diet record and blood collection	Nutrition status of EoE will be assessed by the collection a 3-day diet record, vitamin D, vitamin B12, iron, total iron binding capacity, and ferritin at baseline and 3 months.	3 months
Growth and development assessed by anthropometric measure	Z-scores for height and weight will be collected at baseline and at 3 months.	3 months

Collaborators and Investigators

• Sponsor: Kate Farms Inc
• Collaborators: Seattle Children's Hospital
• Investigators: Principal Investigator: Michael Pickens, DO, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis; penclomedine
• Other Study ID Numbers: Seattle2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No