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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07340593
Enrollment
1251
Registered
2026-01-14
Start date
2023-12-18
Completion date
2025-06-07
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer Screening, Helicobacter Eradication, Helicobacter Infections, Prevention and Control

Keywords

gastric cancer, helicobacter pylori, Laos, H pylori eradication, cancer prevention

Brief summary

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.

Detailed 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.

Interventions

None listed

Sponsors

Oita University
CollaboratorOTHER
Setthathirath Hospital
CollaboratorOTHER
Mahosot Hospital, Laos
CollaboratorUNKNOWN
Lao National Cancer Center
CollaboratorOTHER
Zero Helicobacter IGAN Network
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of H. pylori infection • Method: Stool antigen test • Time Frame: BaselineBaselineThe 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

MeasureTime frameDescription
H. pylori eradication rate after triple therapy,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

MeasureTime frameDescription
Prevalence of gastric cancerBaseline endoscopyNumber of gastric cancer detected during screening endoscopy among high-risk participants (≥40 years, H. pylori positive).

Countries

Laos

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026