Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction of F. Nucleatum in Saliva
研究概览
简要总结
This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome
详细描述
Patients scheduled for upper endoscopy for clinical indications will be randomized to 3 weeks of either no treatment or use of twice daily chlorhexidine mouthwash leading up to the endoscopy. There will be 2-3 study visits, at Day 0 and Day 21, and for those subjects in the mouthwash arm, a final visit 1-2 weeks following the Day 21 visit. Subjects will be required to fast overnight prior to the visits on Days 0 and 21.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled for upper endoscopy for clinical indications
- •No allergy or other contraindication to chlorhexidine
排除标准
- •Use of proton pump inhibitors or H2 receptor antagonists within 1 month of enrollment. Acid suppressant medications raise the gastric pH and can dramatically alter the gastric and esophageal microbiome.
- •History of upper gastrointestinal cancer
- •History of histologically proven Barrett's esophagus
- •History of antireflux or bariatric surgery, or other gastric or esophageal surgery
- •Use of antimicrobial mouthwash within 1 month of enrollment
- •Use of antibiotics or immunosuppressant medications within 3 months of enrollment
- •Use of steroid inhalers or nasal sprays within 1 month of enrollment
- •HIV or other immunosuppressed states or conditions (e.g. active malignancy)
- •Pregnant or breast feeding
- •Inability to give informed consent
研究组 & 干预措施
Antibacterial mouthwash
Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.
干预措施: Chlorhexidine gluconate (Drug)
结局指标
主要结局
Reduction of F. Nucleatum in Saliva
时间窗: 21 days
Within individual change in relative abundance of F nucleatum in oral samples
Difference in Esophageal F. Nucleatum Between Experimental Group and no Intervention Group
时间窗: 21 days
Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.
次要结局
未报告次要终点