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临床试验/NCT05176262
NCT05176262进行中(未招募)不适用

A Prospective Study of the Four Food Elimination Diet for Treatment of Eosinophilic Esophagitis

Ann & Robert H Lurie Children's Hospital of Chicago1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
64
试验地点
1
主要终点
Efficacy of the Four Food Elimination Diet

研究概览

简要总结

This study is to observe the efficacy of the four food elimination diet.

详细描述

The goals of treatment in EoE, like for most other chronic disorders, include: 1) resolution of clinical symptoms, 2) maintenance of remission and prevention of disease relapse 3) prevention of complications such as fibrosis and strictures by maintaining histological remission 4) prevention of iatrogenic treatment related adverse reactions such as nutritional deficiencies as in dietary treatment and 5) maintenance of quality of life.

Current standard of care for the treatment of EoE include either pharmacologic modality with glucocorticosteroids (oral, or swallowed spray or slurry) or diet. Swallowed steroids are the more commonly utilized form of steroid treatment modality with histological remission rates of 50-80% of subjects. The potential drawbacks of steroid therapy include side effects such as opportunistic infections, potential suppression of the pituitary-adrenal axis with prolonged use and most important disease recurrence once the medication is discontinued.

The dietary approach is based on the hypothesis that food antigen(s) trigger eosinophilic inflammation and clinical and histological remission can be induced by identifying and excluding the causative food antigen(s). It is believed that eliminating causative food antigen(s) target the cause and thus induces long term remission. The current recommendation for treatment of EoE with diet are based on a number of retrospective and observational studies.

This prospective study eliminating the four most common (cow milk protein, wheat, egg, and soy) antigens, will primarily assess the histological response in a cohort of children and will attempt to validate the findings of the previously published retrospective study. In addition by the process of orderly and sequential reintroduction of the excluded solids the investigators will identify the different foods responsible for causing esophageal inflammation and thus disease. This study will also characterize patient demographics, symptoms and histologic changes associated with the four food elimination (4-FED) process.

Health outcomes in children and adolescents related to EoE primarily focus on symptoms and histology. This does not take into consideration the health related quality of life (HRQOL), which may be conceptualized to include physical health, mental health, social functioning, role functioning, and general health perceptions.10 HRQOL has been shown to affect patient satisfaction with and adherence to treatment, and therefore long term outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients ages 12 months-18 years
  • •Presence of clinical symptoms related to esophageal dysfunction such as: feeding aversion, failure to thrive, vomiting, abdominal pain, dysphagia, heartburn, and food impaction
  • •Histologic criteria for the diagnosis of EoE with ≥15 eosinophils per high power field from review of a total of six biopsies obtained from the distal and mid (three from each site) esophagus in subjects who were adequately pre-treated with a proton-pump inhibitor- 1mg/kg/dose twice daily, up to a maximum of 40mg or 30mg per dose depending on preparation for 6-8 weeks or had a normal 24 hour ph probe study18
  • •Patients who agree to 4-FED as their treatment of EoE

排除标准

  • •Those patients who are on oral or swallowed steroids (prior use of steroids that was discontinued more than two months prior to enrollment does not constitute an exclusion criterion)
  • •Patients who are unable to tolerate the 4-FED
  • •Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis

研究组 & 干预措施

4FED Group

EoE patients recruited to this observational study will be monitored for treatment response to 4FED and treatment responders will be monitored during food reintroduction

结局指标

主要结局

Efficacy of the Four Food Elimination Diet

时间窗: every 6-12 months, at standard of score endoscopies

Demonstrate the efficacy of the empiric 4-FED in inducing clinical and histological remission in children with EoE.

次要结局

  • Allergy skin prick correlation(every 6-12 months, at standard of score endoscopies)
  • Determining most common and least common food trigger(every 6-12 months, at standard of score endoscopies)
  • Food reintroduction Quality of Life measurement(every 6-12 months, at standard of score endoscopies)
  • Identifying food triggers(every 6-12 months, at standard of score endoscopies)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Wechsler

Attending Physician, Gatroenterology, Hepatology & Nutrition

Ann & Robert H Lurie Children's Hospital of Chicago

研究点 (1)

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