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

NCT07211880 | Completed

• 1 other identifier: PO/2019/076
• Study Type: interventional
• Target: 1,043
• Locations: 1 country
• Sites: 1

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.

Conditions

H.Pylori; Gastric Cancer; H Pylori Eradication

Keywords

H. pylori; gastric cancer; H pylori eradication triple therapy; Bhutan

Outcome Measures

Primary Outcomes (2)

• Prevalence of H. pylori

  The seroprevalence of H. pylori (IgG ≥10 U/m) as positive for the H pylori

  2 months

• Gastric atrophy by pepsinogen test

  As a marker of gastric atrophy, serum levels of pepsinogen I and II were measured using a chemiluminescence enzyme immunoassay (E-Plate Eiken Disc Pepsinogen I and II; Eiken Chemical Co., Ltd., Tochigi, Japan). A positive result in the pepsinogen method was defined as a pepsinogen I level ≤70 ng/mL and a pepsinogen I/II ratio ≤3. Based on the results of both the pepsinogen test and H. pylori IgG levels, participants were classified into four ABC groups (A-D), which reflect the risk of gastric cancer according to the ABC method.

  2 Months

Secondary Outcomes (3)

• Gastrointestinal endoscopic examination

  3 months

• H pylori eradication therapy

  3 months

• Urea Breath Test (UBT) of H pylori eradication therapy

  8 weeks

Study Arms (2)

H pylori positive individual

EXPERIMENTAL

H pylori positive individual receiving triple therapy

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

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).

Device: Urea Breath Test for the prevalence of H pylori

Interventions

Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin DRUG

7 days therapy

H pylori positive individual

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

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

H pylori positive individual

Urea Breath Test for the prevalence of H pylori 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.)

H. pylori positive individuals for UBT test

Eligibility Criteria

• Age: 12 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zero Helicobacter IGAN Network: lead
• Oita University: collaborator
• Japan International Cooperation Agency: collaborator
• JDWNRH: collaborator
• Khesar Gyalpo University of Medical Sciences of Bhutan: collaborator
• Royal Centre for Disease Control Bhutan: collaborator

Study Sites (1)

Khesar Gyalpo University of Medical Sciences of Bhutan

Thimphu, Thimphu District, Bhutan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Rabeprazole; Clarithromycin; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Yumiko Kamogawa, M.D., Ph.D.

  NPO HIGAN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D. President of Zero Helicobacter IGAN Network

Model Details: Screening of H pylori and eradication in order to prevent gastric cancer using community-based longitudinal study

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 8, 2025
• Study Start: December 5, 2019
• Primary Completion: December 11, 2020
• Study Completion: March 21, 2023
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BH (1)