Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis
Purpose
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.
Condition
- Eosinophilic Esophagitis (EoE)
Eligibility
- Eligible Ages
- Between 1 Year and 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
Experimental Dairy free + Partial Enteral Nutrition (PEN) diet |
12 subjects will be enrolled in the diary free and 50% PEN diet |
|
Recruiting Locations
Seattle, Washington 98105
More Details
- Status
- Recruiting
- Sponsor
- Kate Farms Inc
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.