Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis Induction of Remission
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Feasibility of PEN assessed by 3-day diet record
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
12 participants will be control subjects without diagnosis of EoE
Dairy Free
12 subjects will be enrolled in the dairy free diet group.
干预措施: Dairy elimination alone (Other)
Dairy free + Partial Enteral Nutrition (PEN) diet
12 subjects will be enrolled in the diary free and 50% PEN diet
干预措施: Partial enteral nutrition (PEN) with dairy elimination (Other)
结局指标
主要结局
Feasibility of PEN assessed by 3-day diet record
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 3 months
Environmental contaminants assessed by CBC with differential before and after PEN with dairy elimination.
次要结局
- Nutritional status assessed by 3-day diet record and blood collection(3 months)
- Growth and development assessed by anthropometric measure(3 months)