Eosinophilic Esophagitis (EoE)NCT07234825
Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis
A study testing Partial enteral nutrition (PEN) with dairy elimination and Dairy elimination alone in people with Eosinophilic Esophagitis (EoE), run by Kate Farms Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- Partial enteral nutrition (PEN) with dairy elimination and Dairy elimination alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Elizabeth Reznikov, DO, PhD, 206-987-1062, Elizabeth.Reznikov@seattlechildrens.org
Elizabeth Reznikov, DO, PhD
About this study
Official title: Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis Induction of Remission
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.
Read the detailed description
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.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- Partial enteral nutrition (PEN) with dairy elimination, Dairy elimination alone
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial enteral nutrition (PEN) with dairy eliminationOther
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 aloneOther
Participants in this group will be on a dairy-free regular diet alone.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 12 participants will be control subjects without diagnosis of EoE |
| Dairy Free | Experimental | 12 subjects will be enrolled in the dairy free diet group. Receives: Other: Dairy elimination alone |
| Dairy free + Partial Enteral Nutrition (PEN) diet | Experimental | 12 subjects will be enrolled in the diary free and 50% PEN diet Receives: Other: Partial enteral nutrition (PEN) with dairy elimination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Environmental contaminants assessed by blood serum levels
Environmental contaminants assessed by CBC with differential before and after PEN with dairy elimination.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Growth and development assessed by anthropometric measure
Z-scores for height and weight will be collected at baseline and at 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start18 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kate Farms Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Michael Pickens, DO, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234825
- Sponsor's protocol ID
- Seattle2025
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis Induction of Remission
- ClinicalTrials.gov ID
- NCT07234825
- Acronym / sponsor ID
- Seattle2025
- Conditions
- Eosinophilic Esophagitis (EoE)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kate Farms IncIndustry (pharma, biotech, devices)
- Collaborators
- Seattle Children's Hospital
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –12 participants will be control subjects without diagnosis of EoE |
| Dairy Free | Experimental | Other: Dairy elimination alone12 subjects will be enrolled in the dairy free diet group. |
| Dairy free + Partial Enteral Nutrition (PEN) diet | Experimental | Other: Partial enteral nutrition (PEN) with dairy elimination12 subjects will be enrolled in the diary free and 50% PEN diet |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial enteral nutrition (PEN) with dairy eliminationPatients in the PEN with dairy elimination group will receive 50% calories from Kate Farms Standard 1.2 formula and 50% dairy free regular diet. | Other | Dairy free + Partial Enteral Nutrition (PEN) diet |
| Dairy elimination aloneParticipants in this group will be on a dairy-free regular diet alone. | Other | Dairy Free |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Nutritional status assessed by 3-day diet record and blood collection
Time frame: 3 months
Growth and development assessed by anthropometric measure
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Eosinophilic Esophagitis (EoE)
RecruitingPhase 2
A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis
EoE, Eosinophilic Esophagitis
RecruitingPhase 3
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE)
Recruiting
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Dysphagia, Esophageal Stricture
Active, not recruitingObservational study
A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
Eosinophilic Esophagitis (EoE)
Enrolling by invitationObservational study
The DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE), Dysphagia, Esophageal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Pickens, DO principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial enteral nutrition (PEN) with dairy elimination and Dairy elimination alone in people with Eosinophilic Esophagitis (EoE), run by Kate Farms Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danny Gagucas (206-987-1062, Danny.Gagucas@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of PEN assessed by 3-day diet record (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.