Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Demonstrate the efficacy of the empiric single food elimination diet of eliminating cows milk
研究概览
简要总结
The investigators seek to assess the efficacy of removing cow's milk from an EoE patient's diet. This will be determined by esophageal inflammation and clinical and histological response to the milk elimination treatment.
详细描述
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.
This process is difficult as it requires multiple, invasive endoscopies and introduces the possibility of iatrogenic effects such as nutrient deficiency due to simultaneous multiple food eliminations. In addition, patient compliance may be compromised, both intentionally and unintentionally as many families report the elimination process to be both confusing and frustrating.
This prospective study eliminating only cow's milk proteins, which are a common cause of esophageal inflammation in patients with eosinophilic esophagitis, will assess the histological response in a cohort of children receiving care at Lurie Children's.
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
- 是
入选标准
- •Patients aged 1-18
- •Patients who meet the criteria for diagnosis of EoE with ≥15 eosinophils per high power field and who had been previously treated with an adequate dose of PPI for 6-8 weeks or had a normal 24 hour ph probe study will be recruited from the patients seen by one of the physicians in the EoE clinic at Lurie Children's and other participating centers
- •Patients who agree to cow's milk elimination diet as their treatment of EoE
排除标准
- •Patients who started 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 cow's milk elimination diet
- •Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis
结局指标
主要结局
Demonstrate the efficacy of the empiric single food elimination diet of eliminating cows milk
时间窗: 1 year
Participants who have eliminated cow's milk will be clinically assessed to determine if histological remission, measured by Eos/hpf, was induced under this diet for children with EOE
次要结局
- Correlate esophageal counts with age of participant as a predictor of response(1 year)
研究者
Joshua Wechsler
Attending Physician, Gatroenterology, Hepatology & Nutrition
Ann & Robert H Lurie Children's Hospital of Chicago