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
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
- H.Pylori
- Gastric Cancer
- H Pylori Eradication
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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