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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
Participants in this group will be on a dairy-free regular diet alone.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Environmental contaminants assessed by blood serum levels
Environmental contaminants assessed by CBC with differential before and after PEN with dairy elimination.
Time frame: 3 months
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Nutritional status assessed by 3-day diet record and blood collection
Nutrition status of EoE will be assessed by the collection a 3-day diet record, vitamin D, vitamin B12, iron, total iron binding capacity, and ferritin at baseline and 3 months.
Time frame: 3 months
Growth and development assessed by anthropometric measure
Z-scores for height and weight will be collected at baseline and at 3 months.
Time frame: 3 months