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Идёт набор NCT07234825

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

Без фазы С лечением Eosinophilic Esophagitis (EoE)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Partial enteral nutrition (PEN) with dairy elimination, Dairy elimination alone.
Кому может быть актуально
Состояния в реестре: Eosinophilic Esophagitis (EoE). Базовые параметры: 1 год — 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое Dairy elimination alone
    Participants in this group will be on a dairy-free regular diet alone.

Первичные конечные точки

  • Feasibility of PEN assessed by 3-day diet record [Срок оценки: 3 months]
  • Tolerability of PEN in EoE patients will be assessed by stool quality evaluated using the Bristol Stool Chart. [Срок оценки: 3 months]
  • Clinical and endoscopic remission rates assessed by mucosal eosinophilia and Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) from GI tissue biopsies [Срок оценки: 3 months]
  • Immune profiles assessed by blood markers [Срок оценки: 3 months]
  • Microbiota shifts in EoE patients [Срок оценки: 3 months]
  • Environmental contaminants assessed by blood serum levels [Срок оценки: 3 months]
Вторичные конечные точки (2)
  • Nutritional status assessed by 3-day diet record and blood collection [Срок оценки: 3 months]
  • Growth and development assessed by anthropometric measure [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Seattle Children's Hospital — Seattle

Идентификаторы

NCT: NCT07234825 · Seattle2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗