Eosinophilic Esophagitis Clinical Therapy Comparison Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Peak Number of Eosinophils/High Powered Field
研究概览
简要总结
Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to swallow, and this leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and poor growth or weight loss in children
The main purpose of this research study is to compare the effectiveness of two different types of treatment for EoE:
- Oral viscous budesonide- which is a steroid medication that has been used to treat asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation in EoE, and
- Specific food elimination.
The study will also be looking to see if a blood test is useful in following the progression of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more "invasive test."
详细描述
This study is a open label, randomized, prospective clinical trial comparing the efficacy of a topical steroid preparation to an antigen (food) elimination diet.
A total of 40 participants will be recruited for this study that are positive for food allergens. Study participants will be randomly assigned to treatments as described below, and the duration of each treatment phase will be 16 weeks.
The subjects will be randomized to group A and B. Subject and study team will NOT be blinded to the group assignments.
Group A will receive oral viscous budesonide at a dose of 1 or 2 mg daily depending on the height.
Group B will receive an elimination diet (elimination of the foods the subject is allergic to).
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Positive for food allergy: Group A
Oral Budesonide
干预措施: Oral Budesonide (Drug)
Positive for food allergy: Group B
Elimination diet
干预措施: Elimination diet (Other)
结局指标
主要结局
Peak Number of Eosinophils/High Powered Field
时间窗: 16 weeks
The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.
次要结局
- Symptom Score(16 weeks)
- Quality of Life Survey Score(16 weeks)
- Exploratory Studies(Conclusion of study)
研究者
Carla McGuire Davis
Assistant Professor
Baylor College of Medicine