A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Luangprabang and Champasak Province, in Lao PDR 2025.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,251
- 试验地点
- 1
- 主要终点
- Prevalence of H. pylori infection • Method: Stool antigen test • Time Frame: Baseline
研究概览
简要总结
This study aims to determine the regional prevalence of Helicobacter pylori infection, bacterial strain differences, and the prevalence of gastric cancer in two provinces of Laos, a multi-ethnic country where these factors may vary by region and ethnicity. The study also evaluates whether H. pylori eradication therapy contributes to disease prevention. Residents aged 18 years or older in Luang Prabang Province and Champasak Province underwent stool antigen testing, and H. pylori-positive individuals received eradication therapy. High-risk participants aged ≥40 years underwent upper gastrointestinal endoscopy for early detection of gastric cancer.
详细描述
This population-based study was conducted in Laos to investigate geographic variation in Helicobacter pylori infection, bacterial strains, and the prevalence of precancerous and cancerous gastric lesions. Laos is a multi-ethnic nation, and differences in H. pylori prevalence and strain distribution are expected across ethnic groups and regions. The goal of this study is to assess the current burden of infection and evaluate the effectiveness of eradication therapy as a preventive strategy for gastric cancer.
Eligible participants were residents aged ≥18 years living in Luang Prabang Province (North) and Champasak Province (South). The study received approval from the Ethics Committee of the Ministry of Health of Laos. All participants received an explanation of the risks and benefits of screening and provided written informed consent.
The study procedures were conducted as follows:
- Stool H. pylori antigen rapid test was performed for all enrolled participants.
- Participants aged ≥40 years who tested positive were considered a high-risk group and underwent upper gastrointestinal endoscopy for early detection of precancerous gastric lesions and gastric cancer.
- All H. pylori-positive participants received 14-day triple therapy consisting of lansoprazole, amoxicillin, and clarithromycin.
- Eradication was assessed using a follow-up stool antigen test at 8 months after treatment in Luang Prabang Province and 6 months after treatment in Champasak Province.
Screening in Luang Prabang Province was conducted between December 2023 and October 2024, and screening in Champasak Province between October 2024 and June 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Resident of Luangprabang or Champasak Province
- •Able to provide written informed consent
排除标准
- •Severe comorbidities contraindicating screening or treatment
- •Allergy to medications used in triple therapy
- •Pregnant or breastfeeding women (if applicable)
研究组 & 干预措施
Residents of Luang Prabang Province
Residents aged ≥18 years in Luang Prabang Province who underwent stool antigen testing for H. pylori.
Participants ≥40 years who tested positive additionally underwent upper endoscopy.
All positive individuals received triple therapy and were followed for eradication.
Residents of Champasak Province
Residents aged ≥18 years in Champasak Province who underwent stool antigen testing for H. pylori.
Participants ≥40 years who tested positive additionally underwent upper endoscopy.
All positive individuals received triple therapy and were followed for eradication.
结局指标
主要结局
Prevalence of H. pylori infection • Method: Stool antigen test • Time Frame: Baseline
时间窗: Baseline
The proportion of participants who test positive for H. pylori infection using a stool antigen rapid test at baseline. All enrolled residents aged ≥18 years in Luang Prabang Province and Champasak Province undergo stool antigen testing. H. pylori positivity is defined according to the manufacturer's validated cutoff value. This measure provides a population-based estimate of the current H. pylori infection prevalence in two geographically distinct regions of Laos.
次要结局
- H. pylori eradication rate after triple therapy,(6-8 months after treatment completion,)