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

NCT ID: NCT07211880

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1043 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-05
• Study Completion Date: 2023-03-21

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

H pylori positive individual

H pylori positive individual receiving triple therapy

Group Type: EXPERIMENTAL

Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin

Intervention Type: DRUG

7 days therapy

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

Intervention Type: DIAGNOSTIC_TEST

Endoscopic examinations were conducted using a GIF-150 endoscope in combination with the CV150 system (Olympus Co., Tokyo, Japan).

H. pylori positive individuals for UBT test

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).

Group Type: EXPERIMENTAL

Urea Breath Test for the prevalence of H pylori

Intervention Type: DEVICE

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.)

Interventions

Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin

7 days therapy

Intervention Type: DRUG

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).

Intervention Type: DIAGNOSTIC_TEST

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.)

Intervention Type: DEVICE

Eligibility Criteria

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

• Pre-existing medical conditions where triple therapy or endoscopy is not recommended (mainly pregnant women, renal diseases, history of breathing difficulty)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oita University

OTHER

Sponsor Role: collaborator

Japan International Cooperation Agency

OTHER

Sponsor Role: collaborator

JDWNRH

OTHER

Sponsor Role: collaborator

Khesar Gyalpo University of Medical Sciences of Bhutan

UNKNOWN

Sponsor Role: collaborator

Royal Centre for Disease Control Bhutan

UNKNOWN

Sponsor Role: collaborator

Zero Helicobacter IGAN Network

OTHER

Sponsor Role: lead

Responsible Party

Yumiko Kamogawa

M.D., Ph.D. President of Zero Helicobacter IGAN Network

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yumiko Kamogawa, M.D., Ph.D.

Role: STUDY_DIRECTOR

NPO HIGAN

Locations

Khesar Gyalpo University of Medical Sciences of Bhutan

Thimphu, Thimphu District, Bhutan

Countries

Bhutan

Other Identifiers

PO/2019/076

Identifier Type: -

Identifier Source: org_study_id