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

Kate Farms

Status: Not yet enrolling

Conditions: Eosinophilic Esophagitis (EoE)

Treatments: Other: Dairy elimination alone; Other: Partial enteral nutrition (PEN) with dairy elimination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07234825

Seattle2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Control

No Intervention group

Description:

12 participants will be control subjects without diagnosis of EoE

Dairy Free

Experimental group

Description:

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

Treatment:

Other: Dairy elimination alone

Dairy free + Partial Enteral Nutrition (PEN) diet

Experimental group

Description:

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

Treatment:

Other: Partial enteral nutrition (PEN) with dairy elimination