NCT03060733已完成不适用
Helicobacter Pylori Sample Collection Protocol POST-THERAPY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Helicobacter pylori Stool Collection
研究概览
简要总结
The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
详细描述
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 22 years, either gender
- •Subject previously diagnosed with H. pylori infection
- •Subject received and completed FDA approved treatment option
- •Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment option
- •Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared Fecal Antigen Test
- •Subject will undergo EGD and gastric biopsy as part of routine care to measure H. pylori post-therapy response
- •Biopsy is obtained from antrum and/or corpus and is tested by CRM
- •At least two of the three CRM tests are performed
- •Subject whose EGD with biopsy occurred ≤ 7 days prior to stool collection
- •Willing and able to sign the IRB approved Informed Consent form for this study project
排除标准
- •Subject with current severe H. pylori infection
- •Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4 weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors prior to collection
- •Pregnant or lactating
- •Inability or unwilling to perform required study procedures
- •Subject is unable or unwilling to provide informed consent
结局指标
主要结局
Helicobacter pylori Stool Collection
时间窗: Through Study Completion, an average of 1 year
In vitro diagnostic (IVD) device performance
次要结局
未报告次要终点
研究者
研究点 (5)
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