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

NCT07340593 | Completed

• 1 other identifier: 1015/REC
• Study Type: observational
• Target: 1,251
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of H. pylori infection • Method: Stool antigen test • 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.

  Baseline

Secondary Outcomes (1)

• H. pylori eradication rate after triple therapy,

  6-8 months after treatment completion,

Other Outcomes (1)

• Prevalence of gastric cancer

  Baseline endoscopy

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Locations 1. Luangprabang Province, Lao PDR 2. Champasak Province, Lao PDR

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahosot Hospital, Laos: collaborator
• Lao National Cancer Center: collaborator
• Oita University: collaborator
• Setthathirath Hospital: collaborator
• Zero Helicobacter IGAN Network: lead

Study Sites (1)

National Cancer Center

Vientiane, Capital, 0100, Laos

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gastric biopsy samples for molecular analysis of antimicrobial resistance

MeSH Terms

Conditions

Helicobacter Infections; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 14, 2026
• Study Start: December 18, 2023
• Primary Completion: October 10, 2024
• Study Completion: June 7, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)