跳至主要内容
临床试验/NCT02894892
NCT02894892已完成不适用

Intragastric pH and Bismuth Effect for H. Pylori Eradication

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年11月15日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

(A)Bismuth

Active Comparator

(A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy

干预措施: (A)Bismuth (Drug)

(B)Bismuth

Active Comparator

(B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon

干预措施: (B)Bismuth (Drug)

(C)Bismuth

Active Comparator

(C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day

干预措施: (C)Bismuth (Drug)

(D)Esomeprazole and Bismuth

Active Comparator

(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

Active Comparator

(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

Active Comparator

(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

Other

(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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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