Intragastric pH and Bismuth Effect for H. Pylori Eradication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The morphological changes of post-drug H. pylori by electron microscopy.
研究概览
简要总结
Gastric cancer is one of the leading causes of cancer-related deaths worldwide. In Taiwan, there are around 3800 fresh cases annually, with about 5% of total cancers cases. Gastric cancer development is known to follow a multistate process from non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, dysplasia, and carcinoma; H. pylori infection plays the key role of this carcinogenic process. Although H. pylori eradication would result in a marked gastric cancer reduction, treatment success using standard regimens has become more difficult in recent years, and increased antibiotic resistance is considered the most important reason for decreased treatment efficacy. As no specific new medications have been introduced in recent years, novel treatment regimens have been created using different combinations, durations and sequences of available medications. The addition of bismuth improved the cure rates despite a high prevalence of resistance, and resistance of H. pylori to bismuth has not been reported. Bismuth absorption is not required for efficacy in H. pylori treatment regimens, suggesting a local mechanism of action. The mechanisms of bismuth with responsible for rapid destruction of H. pylori within the stomach remain unclear. Knowledge of the mechanism of action of bismuth compounds against H. pylori would be beneficial in the development of improved treatment regimens in this era of declining eradication success rates. We conduct the pilot study to evaluate the bacteria fragments of H. pylori in specimen through electron microscopy after bismuth therapy and provide insight into the mechanism of action of pH on bismuth therapy. We also help to develop optimal H. pylori therapeutic strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 69 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
(A)Bismuth
(A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy
干预措施: (A)Bismuth (Drug)
(B)Bismuth
(B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon
干预措施: (B)Bismuth (Drug)
(C)Bismuth
(C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day
干预措施: (C)Bismuth (Drug)
(D)Esomeprazole and Bismuth
(D)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy
干预措施: (D)Esomeprazole and Bismuth (Drug)
(E)Esomeprazole and Bismuth
(E)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon
干预措施: (E)Esomeprazole and Bismuth (Drug)
(F)Esomeprazole and Bismuth
(F)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) q.i.d. and endoscopy the next day
干预措施: (F)Esomeprazole and Bismuth (Drug)
(G)Control
(G)These patients underwent endoscopy due to abdominal discomfort or other symptoms and did not have cancers in the digestive tract after series of workup.
干预措施: (G)Control (Other)
结局指标
主要结局
The morphological changes of post-drug H. pylori by electron microscopy.
时间窗: 3 years
Endoscopy: The biopsy procedure protocol specified sampling gastric mucosa in the locations of gastric antrum, body and cardia (two specimens from each location). Specimens would be sent for electron microscopy. Electron microscopy: Bacteria fragments of H. pylori would be observed.
次要结局
未报告次要终点
