A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Bhutan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,043
- 试验地点
- 1
- 主要终点
- Prevalence of H. pylori
研究概览
简要总结
Background: Helicobacter pylori is a major risk factor for gastric cancer, yet in many developing countries, including Bhutan where gastric cancer incidence is high, access to screening and eradication is limited. The investigators conducted the first large-scale, population-based survey of H. pylori infection and gastric disease in Bhutan to provide baseline data before the launch of a national gastric cancer prevention program.
Methods: Permanent residents aged ≥12 years from 24 villages under Dawakha Basic Health Unit II catchment area were enrolled (December 2019-March 2023). H. pylori status was determined by serum IgG testing, gastric atrophy by serum pepsinogen, and endoscopy was offered to high-risk groups.
详细描述
The investigators enrolled permanent residents aged ≥12 years living in communities within the catchment area of Dawakha BHU II, Paro District, Bhutan, between December 2019 and March 2023. The objectives of this study were to evaluate the status of H. pylori infection, the prevalence of endoscopic gastric diseases including gastric cancer and peptic ulcers, and to provide eradication therapy for infected individuals. Exclusion criteria included individuals with medical conditions in which triple therapy or endoscopy was contraindicated (e.g., pregnancy, renal disease, history of respiratory difficulty), those with a prior history of H. pylori eradication therapy, and individuals who declined to provide informed consent.
The study protocol complied with the ethical principles of the Declaration of Helsinki and was approved by the Institutional Review Board of Khesar Gyalpo University of Medical Sciences of Bhutan (approval number: PO/2019/076). Written informed consent was obtained from all participants. This prospective clinical trial was registered on July 1, 2021, in the University Hospital Medical Information Network (UMIN), under the identifier UMIN000044707 (http://www.umin.ac.jp/ctr/index.htm).
All participants underwent H. pylori serological testing and measurement of serum pepsinogen levels to assess infection status and evaluate the degree of serological gastric atrophy, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Both male and female age 12 years and above in the selected communities for H. pylori infection screening
- •Both male and female age 18 years and above in the selected communities for H. pylori infection screening, eradication and endoscopy.
- •Permanent residence of the communities
排除标准
- •Exclusion criteria for screening
- •Individuals not consenting Exclusion criteria for eradication and endoscopy
- •Pre-existing medical conditions where triple therapy or endoscopy is not recommended (mainly pregnant women, renal diseases, history of breathing difficulty)
研究组 & 干预措施
H pylori positive individual
H pylori positive individual receiving triple therapy
干预措施: Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin (Drug)
H pylori positive individual
H pylori positive individual receiving triple therapy
干预措施: Upper gastrointestinal endoscopy for the H. pylori and serum pepsinogen positive individuals (high risk group of gastric cancer) (Diagnostic Test)
H. pylori positive individuals for UBT test
The H pylori positive individuals are treated by triple therapy. After 6-8 weeks, the eradication is confirmed by using the UBT (13C Urea Breath Test: Beijing Richen-force Science & Technology Co. Ltd).
干预措施: Urea Breath Test for the prevalence of H pylori (Device)
结局指标
主要结局
Prevalence of H. pylori
时间窗: 2 months
The seroprevalence of H. pylori (IgG ≥10 U/m) as positive for the H pylori
Gastric atrophy by pepsinogen test
时间窗: 2 Months
As a marker of gastric atrophy, serum levels of pepsinogen I and II were measured using a chemiluminescence enzyme immunoassay (E-Plate Eiken Disc Pepsinogen I and II; Eiken Chemical Co., Ltd., Tochigi, Japan). A positive result in the pepsinogen method was defined as a pepsinogen I level ≤70 ng/mL and a pepsinogen I/II ratio ≤3. Based on the results of both the pepsinogen test and H. pylori IgG levels, participants were classified into four ABC groups (A-D), which reflect the risk of gastric cancer according to the ABC method.
次要结局
- Gastrointestinal endoscopic examination(3 months)
- H pylori eradication therapy(3 months)
- Urea Breath Test (UBT) of H pylori eradication therapy(8 weeks)
研究者
Yumiko Kamogawa
M.D., Ph.D. President of Zero Helicobacter IGAN Network
Zero Helicobacter IGAN Network