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

NCT ID: NCT07234825

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-12-31

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.

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.

Conditions

Eosinophilic Esophagitis (EoE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

12 participants will be control subjects without diagnosis of EoE

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dairy Free

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

Group Type: EXPERIMENTAL

Dairy elimination alone

Intervention Type: OTHER

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

Dairy free + Partial Enteral Nutrition (PEN) diet

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

Group Type: EXPERIMENTAL

Partial enteral nutrition (PEN) with dairy elimination

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Dairy elimination alone

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

Kate Farms Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Pickens, DO

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Central Contacts

Danny Gagucas

Role: CONTACT

Danny.Gagucas@seattlechildrens.org

206-987-1062

Other Identifiers

Seattle2025

Identifier Type: -

Identifier Source: org_study_id