Helicobacter Pylori Infection and Gastric Diseases in Lao PDR: First Community-Wide Population-Based Study

Zero Helicobacter IGAN Network

Status: Completed

Conditions: Helicobacter Infections; Helicobacter Eradication; Gastric Cancer Screening; Prevention and Control

Study type: Observational

Funder types: Other

Identifiers

NCT07340593

1015/REC

Details and patient eligibility

About

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.

Full description

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:

1. Stool H. pylori antigen rapid test was performed for all enrolled participants.
2. 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.
3. All H. pylori-positive participants received 14-day triple therapy consisting of lansoprazole, amoxicillin, and clarithromycin.
4. 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.

Enrollment: 1,251 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Resident of Luangprabang or Champasak Province
• Able to provide written informed consent

Exclusion criteria

• Severe comorbidities contraindicating screening or treatment
• Allergy to medications used in triple therapy
• Pregnant or breastfeeding women (if applicable)

Trial design

1,251 participants in 2 patient groups

Residents of Luang Prabang Province

Description:

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

Description:

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.