Gamma-Glutamyl Transpeptidase (GGT): A Potential Diagnostic Marker for Helicobacter Pylori Infections
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stool anti-GGT for the diagnosis of Helicobactor Pylori Infection
研究概览
简要总结
The investigators hypothesis:
Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.
详细描述
Subjects will be requested to provide 1-5g of their solid/semi-solid stool sample, to be collected within 24 hours prior to their scheduled visit for urea breath test. Patients should not have been treated for H. pylori prior to stool collection. Stool samples will be tested using ELISA for the presence of the H. pylori GGT antigen using monoclonal antibodies against GGT. Stool samples will also be tested for the presence of H. pylori DNA using PCR and Western blot analysis respectively.
Presence of the GGT antigen in stool will be compared between H. pylori-positive and H. pylori-negative patients. Rapid urease test results will be used as the gold standard of H. pylori diagnosis. The sensitivity and specificity of the stool antigen test will be established.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is greater than 21 years of age.
- •The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
- •The subject must be willing and able to comply with scheduled visits and other study procedures.
排除标准
- •Subjects who have been taking antibiotics over the past 1 month will be excluded from study.
结局指标
主要结局
Stool anti-GGT for the diagnosis of Helicobactor Pylori Infection
时间窗: 1 month after stool samples collected
1-5g of stool samples will also be collected from patients recruited to this study, in a preliminary investigation to determine the sensitivity and specificity of a stool H.pylori antigen test. Rapid urese test is the gold standard.
次要结局
未报告次要终点
研究者
Gastroenterology & Hepatology
Prof Yeoh Khay Guan
National University Hospital, Singapore