NCT07211880

Helicobacter Pylori Infection and Gastric Disease in Bhutan: First Community-Wide, Population-Based Study

A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Bhutan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,043 (actual)
• Sponsor: Zero Helicobacter IGAN Network · Academic / Other
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Background: Helicobacter pylori is a major risk factor for gastric cancer, yet in many developing countries, including Bhutan where gastric cancer incidence is high, access to screening and eradication is limited. The investigators conducted the first large-scale, population-based survey of H. pylori infection and gastric disease in Bhutan to provide baseline data before the launch of a national gastric cancer prevention program. Methods: Permanent residents aged ≥12 years from 24 villages under Dawakha Basic Health Unit II catchment area were enrolled (December 2019-March 2023). H. pylori status was determined by serum IgG testing, gastric atrophy by serum pepsinogen, and endoscopy was offered to high-risk groups.

Detailed description

The investigators enrolled permanent residents aged ≥12 years living in communities within the catchment area of Dawakha BHU II, Paro District, Bhutan, between December 2019 and March 2023. The objectives of this study were to evaluate the status of H. pylori infection, the prevalence of endoscopic gastric diseases including gastric cancer and peptic ulcers, and to provide eradication therapy for infected individuals. Exclusion criteria included individuals with medical conditions in which triple therapy or endoscopy was contraindicated (e.g., pregnancy, renal disease, history of respiratory difficulty), those with a prior history of H. pylori eradication therapy, and individuals who declined to provide informed consent. The study protocol complied with the ethical principles of the Declaration of Helsinki and was approved by the Institutional Review Board of Khesar Gyalpo University of Medical Sciences of Bhutan (approval number: PO/2019/076). Written informed consent was obtained from all participants. This prospective clinical trial was registered on July 1, 2021, in the University Hospital Medical Information Network (UMIN), under the identifier UMIN000044707 (http://www.umin.ac.jp/ctr/index.htm). All participants underwent H. pylori serological testing and measurement of serum pepsinogen levels to assess infection status and evaluate the degree of serological gastric atrophy, respectively.

Conditions

• H.Pylori
• Gastric Cancer
• H Pylori Eradication

Interventions

Type	Name	Description
DRUG	Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin	7 days therapy
DIAGNOSTIC_TEST	Upper gastrointestinal endoscopy for the H. pylori and serum pepsinogen positive individuals (high risk group of gastric cancer)	Endoscopic examinations were conducted using a GIF-150 endoscope in combination with the CV150 system (Olympus Co., Tokyo, Japan).
DEVICE	Urea Breath Test for the prevalence of H pylori	After eradication of the H pylori with drug success of the therapy was assessed 6 to 8 weeks after treatment using the UBT(C13 Urea Breath Test: Beijing Richen-Force Science \& Techinology Co. Ltd.)

Timeline

• Start date: 2019-12-05
• Primary completion: 2020-12-11
• Completion: 2023-03-21
• First posted: 2025-10-08
• Last updated: 2025-10-08

Locations

1 site across 1 country: Bhutan