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

Zero Helicobacter IGAN Network

Status: Completed

Conditions: H Pylori Eradication; Gastric Cancer; H.Pylori

Treatments: Diagnostic Test: Upper gastrointestinal endoscopy for the H. pylori and serum pepsinogen positive individuals (high risk group of gastric cancer); Drug: Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin; Device: Urea Breath Test for the prevalence of H pylori

Study type: Interventional

Funder types: Other

Identifiers

NCT07211880

PO/2019/076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,043 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Both male and female age 12 years and above in the selected communities for H. pylori infection screening

  • Both male and female age 18 years and above in the selected communities for H. pylori infection screening, eradication and endoscopy.
  • Permanent residence of the communities

Exclusion criteria

• Exclusion criteria for screening

  • Individuals not consenting Exclusion criteria for eradication and endoscopy
  • Pre-existing medical conditions where triple therapy or endoscopy is not recommended (mainly pregnant women, renal diseases, history of breathing difficulty)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,043 participants in 2 patient groups

H pylori positive individual

Experimental group

Description:

H pylori positive individual receiving triple therapy

Treatment:

Drug: Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin

Diagnostic Test: Upper gastrointestinal endoscopy for the H. pylori and serum pepsinogen positive individuals (high risk group of gastric cancer)

H. pylori positive individuals for UBT test

Experimental group

Description:

The H pylori positive individuals are treated by triple therapy. After 6-8 weeks, the eradication is confirmed by using the UBT (13C Urea Breath Test: Beijing Richen-force Science \& Technology Co. Ltd).

Treatment:

Device: Urea Breath Test for the prevalence of H pylori