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

ConditionEosinophilic Esophagitis (EoE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-21
SponsorKate Farms Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Partial enteral nutrition (PEN) with dairy elimination

    Other intervention

    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 intervention

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

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Dairy FreeExperimental treatment 1 intervention
Group C: Dairy free + Partial Enteral Nutrition (PEN) dietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months
4

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.

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months
2

Growth and development assessed by anthropometric measure

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

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kate Farms Inc

Lead sponsor

Seattle Children's Hospital

Collaborator

Source ClinicalTrials.gov
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