Study of a Dietary Supplement for Reflux During Sleep
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Reduction in symptoms associated with GERD
研究概览
简要总结
This research study is a randomized, controlled study developed to test how well a dry mouth product that contains xylitol affects some of the symptoms of gastroesophageal reflux disease (GERD. Individuals who experience symptoms of gastro esophageal reflux disease (GERD) and who are accepted into the study will be asked to report on the frequency and severity of several symptoms specific to the condition that occur during sleep. The study is composed of two phases:
Phase one involves collection of baseline information for two weeks. Phase two is the intervention phase of the study. In this phase of the study, each subject will be randomly assigned (like flipping a coin) to use either "the product" of interest or a different dry mouth product for two weeks.
详细描述
The study is composed of two phases:
Phase one involves collection of baseline information for two weeks. Phase two is the intervention phase of the study. In this phase of the study, each subject will be randomly assigned (like flipping a coin) to use either "the product" of interest or a different dry mouth product for two weeks.
Phase 1
This first phase will involve having you report to the research coordinator through email the presence or absence of several symptoms associated with GERD that can occur during sleep. Phase 1 will occur over 14 days (and nights). You will also be asked to rate the relative severity of some of the symptoms. The information collected during this initial phase of the study will then be used to establish baseline values for the symptoms of interest and determine your eligibility for the intervention phase (phase 2) of the study.
Phase 2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A medical diagnosis of GERD
- •Awakening with a taste of refluxed stomach acid in the mouth
- •Heartburn during sleep
- •Voice hoarseness upon awakening
- •Antacid use at night
- •Dry mouth at bedtime or during the night
- •Experience difficulty chewing, swallowing, and speaking because of dry mouth
排除标准
- •Prior history of any of these conditions:
- •coronary artery disease
- •gallbladder disease
- •gastric or esophageal cancer
- •peptic ulcer disease
- •esophagitis, whether eosinophilic, infectious, or pill based
- •esophageal motility disorders
- •A history of thoracic, esophageal, or gastric surgery
- •No medical examination in the prior year
结局指标
主要结局
Reduction in symptoms associated with GERD
时间窗: two weeks
Email questionnaire containing 9 questions of interest
次要结局
未报告次要终点
研究者
Jeff Burgess DDS MSD
Research Coordinator
Oral Care Research Associates, Seattle