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NCT Number: NCT07340593

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

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.

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Key information

Conditions

Gastric Cancer Screening Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gram-Negative Bacterial Infections Helicobacter Eradication Helicobacter Infections Infections Neoplasms Neoplasms by Site Prevention and Control Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center

Vientiane, Capital, 0100, Laos

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Prevalence of H. pylori infection • Method: Stool antigen test • Time Frame: Baseline

    Time frame: 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.

Secondary outcomes

  1. H. pylori eradication rate after triple therapy,

    Time frame: 6-8 months after treatment completion,

    The percentage of H. pylori-positive participants who achieve eradication following 14-day triple therapy, confirmed by stool antigen testing.

Other outcomes

  1. Prevalence of gastric cancer

    Time frame: Baseline endoscopy

    Number of gastric cancer detected during screening endoscopy among high-risk participants (≥40 years, H. pylori positive).

Sponsors and collaborators

Lead sponsor

Zero Helicobacter IGAN Network

Other

Collaborators

  • Lao National Cancer Center
  • Mahosot Hospital, Laos
  • Oita University
  • Setthathirath Hospital

Registry information

Official study title

A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Luangprabang and Champasak Province, in Lao PDR 2025.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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