Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07234825

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Eosinophilic Esophagitis (EoE) Digestive System Diseases Eosinophilia Eosinophilic Esophagitis Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location status: Recruiting

Location contact

Elizabeth Reznikov, DO, PhD

CONTACT

[email protected]

206-987-1062

Elizabeth Reznikov, DO, PhD

SUB_INVESTIGATOR

Michael Pickens, DO

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Partial enteral nutrition (PEN) with dairy elimination

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.

Dairy elimination alone

Other

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

Primary outcomes

  1. Feasibility of PEN assessed by 3-day diet record

    Time frame: 3 months

    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.

  2. Tolerability of PEN in EoE patients will be assessed by stool quality evaluated using the Bristol Stool Chart.

    Time frame: 3 months

    Bristol stool chart will be used to assess stool quality at 2 weeks and at month 3.

  3. Clinical and endoscopic remission rates assessed by mucosal eosinophilia and Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) from GI tissue biopsies

    Time frame: 3 months

    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.

  4. Immune profiles assessed by blood markers

    Time frame: 3 months

    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.

  5. Microbiota shifts in EoE patients

    Time frame: 3 months

    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.

  6. Environmental contaminants assessed by blood serum levels

    Time frame: 3 months

    Environmental contaminants assessed by CBC with differential before and after PEN with dairy elimination.

Secondary outcomes

  1. Nutritional status assessed by 3-day diet record and blood collection

    Time frame: 3 months

    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.

  2. Growth and development assessed by anthropometric measure

    Time frame: 3 months

    Z-scores for height and weight will be collected at baseline and at 3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Danny Gagucas

CONTACT

[email protected]

206-987-1062

Sponsors and collaborators

Lead sponsor

Kate Farms Inc

Industry

Collaborators

  • Seattle Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.