Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biomerica
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Non-invasive collection procedure
研究概览
简要总结
The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.
详细描述
This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 and to 75 years.
- •Able to read, speak, and understand English or have access to a translator in subject's native language.
- •Patients without prior H. pylori eradication treatment.
- •Currently not on proton pump inhibitors, antibiotics or bismuth
- •Discontinuation at least 2 weeks prior to endoscopy and specimen collection.
- •Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain]
- •Undergo gastric biopsies as part of routine care
- •Physician able to provide histology and rapid urease result on biopsy specimens.
排除标准
- •Aged less than 21 years old or older than 75 years
- •Unable to provide consent.
- •Patients with a history of prior H. pylori eradication therapy.
- •Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue
- •Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y.
- •Any unstable or poorly-controlled medical or psychiatric condition.
结局指标
主要结局
Non-invasive collection procedure
时间窗: 1 year
This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics.
次要结局
未报告次要终点