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

NCT07234825 | Recruiting

• 1 other identifier: Seattle2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eosinophilic Esophagitis (EoE)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Nutritional status assessed by 3-day diet record and blood collection

  3 months

• Growth and development assessed by anthropometric measure

  3 months

Study Arms (3)

Control

NO INTERVENTION

12 participants will be control subjects without diagnosis of EoE

Dairy Free

EXPERIMENTAL

12 subjects will be enrolled in the dairy free diet group.

Other: Dairy elimination alone

Dairy free + Partial Enteral Nutrition (PEN) diet

EXPERIMENTAL

12 subjects will be enrolled in the diary free and 50% PEN diet

Other: Partial enteral nutrition (PEN) with dairy elimination

Interventions

Partial enteral nutrition (PEN) with dairy elimination OTHER

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.

Dairy free + Partial Enteral Nutrition (PEN) diet

Dairy elimination alone OTHER

Participants in this group will be on a dairy-free regular diet alone.

Dairy Free

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kate Farms Inc: lead
• Seattle Children's Hospital: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

penclomedine

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michael Pickens, DO

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Gagucas

CONTACT

206-987-1062; Danny.Gagucas@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 18, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)