Partial enteral nutrition with a dairy-free diet for eosinophilic esophagitis
Official title: Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis Induction of Remission
Run by Kate Farms Inc · NCT07234825 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 21 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Kate Farms Inc Industry-sponsored |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | March 18, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07234825 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.