NCT07234825

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Kate Farms Inc · Industry
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-18
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-11-18
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States