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

NCT07211880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1043

Last updated 2025-10-08

No results posted yet for this study

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.

Conditions

Interventions

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.)

Sponsors & Collaborators

  • Oita University

    collaborator OTHER
  • Japan International Cooperation Agency

    collaborator OTHER
  • JDWNRH

    collaborator OTHER
  • Khesar Gyalpo University of Medical Sciences of Bhutan

    collaborator UNKNOWN
  • Royal Centre for Disease Control Bhutan

    collaborator UNKNOWN
  • Zero Helicobacter IGAN Network

    lead OTHER

Principal Investigators

  • Yumiko Kamogawa, M.D., Ph.D. · NPO HIGAN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2020-12-11
Completion
2023-03-21

Countries

  • Bhutan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211880 on ClinicalTrials.gov