Partial enteral nutrition with a dairy-free diet for eosinophilic esophagitis
Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis Induction of Remission
NA · Kate Farms Inc · NCT07234825
This study tests whether partial enteral nutrition plus a dairy-free diet can bring remission and change immune responses, gut bacteria, and toxin levels in children and young adults with eosinophilic esophagitis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Sponsor | Kate Farms Inc (industry) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT07234825 on ClinicalTrials.gov |
What this trial studies
This interventional study will offer pediatric and young adult patients (ages 1–21) a dietary regimen combining partial enteral nutrition (PEN) with elimination of dairy and compare findings before and three months after the intervention. Investigators will measure clinical and endoscopic remission, adherence, nutritional and anthropometric outcomes, and collect samples to profile immune markers, gut microbiota, and environmental contaminants. The protocol includes baseline evaluation and an endoscopic assessment at three months to determine tissue-level response. The study is sponsored by an industry partner (Kate Farms Inc.) in collaboration with Seattle Children's Hospital and is conducted at that single pediatric center.
Who should consider this trial
Good fit: Children and young adults aged 1 to 21 with symptoms suggestive of EoE who are planning to undergo endoscopy and meet the study's inclusion criteria are eligible.
Not a fit: Patients with excluded conditions—such as autoimmune bowel disease, prior esophageal or intestinal surgery, eating disorders or ARFID, fistulizing or fibrotic disease on baseline endoscopy, recent proton pump inhibitor use, pregnancy, or other exclusion criteria—are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could increase remission rates and offer a less restrictive or more effective dietary option for children and young adults with EoE.
How similar studies have performed: Partial enteral nutrition is an established effective therapy in Crohn's disease and elimination diets have proven effective in EoE, but applying PEN specifically to EoE is relatively novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seattle, Washington
- Seattle Children's Hospital — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Pickens, DO — Seattle Children's Hospital
- Study coordinator: Danny Gagucas
- Email: Danny.Gagucas@seattlechildrens.org
- Phone: 206-987-1062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Eosinophilic Esophagitis