13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Lot to Lot Variability
研究概览
简要总结
The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.
详细描述
In this study participants will participate in one or two arms of the study. In one arm the participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix drug lots. In the second arm, the participants will be administered GEBT tests from the same 13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the FDA-approved labeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 18-85 years old at time of signing the informed consent form
- •Ability to eat test meal and provide breath samples
排除标准
- •History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption.
- •History of abdominal surgery except appendectomy
- •Use of any medications that may alter gastric motility within two days of the study
- •Use of narcotics or anticholinergics within two days of the study
- •Females on hormone replacement therapy other than birth control medications
- •Pregnancy
- •Intolerance or allergy to any component of GEBT test meal
- •History of neurologic or psychiatric disorders
结局指标
主要结局
Lot to Lot Variability
时间窗: up to 3 months
Participant kPCD values at each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be plotted to compare in vivo results across each lot of material
Biological Variability
时间窗: Up to 3 months
Participant kPCD values at each measured timepoint from the same 13C-Spirulina GEBT test meal will be plotted to compare against each other
次要结局
未报告次要终点