Recruiting

Partial Enteral Nutrition

Sponsor:

Kate Farms Inc

Code:

NCT07234825

Conditions

Eosinophilic Esophagitis (EoE)

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Interventions

Partial enteral nutrition (PEN) with dairy elimination

Dairy elimination alone

Study Details

Brief 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.

Conditions

Eosinophilic Esophagitis (EoE)

Study ID

NCT07234825

Start date

Mar 18, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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.

Dairy elimination alone

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

Primary outcome measure

  • Feasibility of PEN assessed by 3-day diet record [ Time Frame: 3 months ]
  • Tolerability of PEN in EoE patients will be assessed by stool quality evaluated using the Bristol Stool Chart. [ 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 [ Time Frame: 3 months ]
  • Immune profiles assessed by blood markers [ Time Frame: 3 months ]
  • Microbiota shifts in EoE patients [ Time Frame: 3 months ]
  • Environmental contaminants assessed by blood serum levels [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Danny Gagucas

206-987-1062Danny.Gagucas@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Elizabeth Reznikov, DO, PhD

206-987-1062Elizabeth.Reznikov@seattlechildrens.org

Principal Investigator:

Michael Pickens, DO

More Information

Sponsor

Kate Farms Inc

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kate Farms Inc on 2026-04-16.