NCT05482256已完成不适用
The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Mucosal impedance 15 minutes after exposure
研究概览
简要总结
The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal, healthy volunteers.
- •Able to swallow pills.
排除标准
- •Personal history of esophageal disease including but not limited to eosinophilic esophagitis, esophageal dysmotility, or GERD/reflux.
- •History of dysphagia (i.e., difficulty swallowing), chronic vomiting, chronic abdominal pain, unintentional weight loss.
- •Celiac disease, inflammatory bowel disease, irritable bowel syndrome, esophageal varices, chronic aspiration, connective tissue disorder, or known parasitic infection.
- •Gelatin allergy.
- •Use of a toothpaste containing SLS within 2 weeks of the study.
- •Pregnancy.
结局指标
主要结局
Change in Mucosal impedance 15 minutes after exposure
时间窗: Baseline, 15 minutes after teeth brushing
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
次要结局
- Change in Mucosal impedance 30 minutes after exposure(Baseline, 30 minutes after teeth brushing)
- Change in Mucosal impedance 45 minutes after exposure(Baseline, 45 minutes after teeth brushing)
- Change in Mucosal impedance 60 minutes after exposure(Baseline, 60 minutes after teeth brushing)
- Change in IL-33 levels(Baseline, approximately 60 minutes after teeth brushing)
研究者
Benjamin L. Wright
Principal Investigator
Mayo Clinic
研究点 (2)
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