NCT05606705已完成不适用
A Pilot Trial of Baked Milk Introduction in Patients With Milk-triggered Eosinophilic Esophagitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Histological remission
研究概览
简要总结
This research is being done to see if patients with milk-triggered EoE are able to tolerate baked milk in their diet and if there is a threshold amount of straight milk that is tolerable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Eosinophilic esophagitis ≥ 15 eosinophils per HPF
- •Going through or completed the six-food elimination diet, with milk only or milk plus one additional food identified as a trigger
排除标准
- •Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
- •Topical swallowed steroids within 8 weeks of study enrollment
- •Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
研究组 & 干预措施
Baked Milk
Experimental
Baked milk introduction into diet
干预措施: Baked Milk (Dietary Supplement)
结局指标
主要结局
Histological remission
时间窗: 6 weeks
Number of patients in histologic remission at the end of a 6 week trial of baked milk. Histologic remission is defined by \<15 eos per HPF on cytosponge.
次要结局
- Symptomatic remission(6 weeks)
研究者
Karthik Ravi, M.D.
Principal Investigator
Mayo Clinic
研究点 (1)
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