NCT05223881撤回不适用
13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of gastric emptying
研究概览
简要总结
The purpose of this research is to determine if an investigational device called the 13C-Spirulina Gastric Emptying Breath Test (GEBT), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with Cystic Fibrosis (CF).
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 4 years* and above with a genetically confirmed diagnosis of CF (*This age was chosen as patients younger than 4 years rarely undergo GES)
- •Actively being followed at the University of Miami CF Center (i.e. seen within the past 5 years at a University of Miami pediatric or adult pulmonology clinic)
排除标准
- •History of abdominal surgeries involving gastrointestinal luminal resection (i.e. small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen). Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded.
- •Gastrointestinal comorbidities that impact absorption such as Inflammatory Bowel Disease and Celiac Disease
- •Known hypersensitivity to Spirulina, egg, milk or wheat allergens
- •Patients not able to consume at least 50% of a standard test meal
- •Pregnant women
- •Adults unable to consent
- •Prisoners
结局指标
主要结局
Rate of gastric emptying
时间窗: 4 hours
The kPCD value (13CO2 excretion rate) at any time t, is proportional to the rate of gastric emptying. Increasing kPCD values represent increasing rates of gastric emptying.
次要结局
- Rate of gastric emptying over time(6 months)
研究者
Daphna Katz
Pediatric Gastroenterology Fellow
University of Miami
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