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Completed

NCT Number: NCT07211880

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

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.

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Key information

Conditions

H.Pylori Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms H Pylori Eradication Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khesar Gyalpo University of Medical Sciences of Bhutan

Thimphu, Thimphu District, Bhutan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin

Drug

7 days therapy

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).

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.)

Primary outcomes

  1. Prevalence of H. pylori

    Time frame: 2 months

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

  2. Gastric atrophy by pepsinogen test

    Time frame: 2 Months

    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.

Secondary outcomes

  1. Gastrointestinal endoscopic examination

    Time frame: 3 months

    Based on the results of the serological tests, upper gastrointestinal endoscopy was performed in participants classified as ABC group, C or D( as high risk of gastric cancer group), as well as those classified as group B who were over 40 years of age. In addition, endoscopy was also conducted for individuals who voluntarily requested the procedure, regardless of their ABC classification.

  2. H pylori eradication therapy

    Time frame: 3 months

    Patients diagnosed with H. pylori infection received a standard 7-day triple therapy regimen consisting of rabeprazole (10 mg twice daily), amoxicillin (750 mg twice daily), and clarithromycin (200 mg twice daily) as the first-line treatment. Medication adherence was confirmed through daily individual telephone calls with each participant.

  3. Urea Breath Test (UBT) of H pylori eradication therapy

    Time frame: 8 weeks

    Success of the H pylori eradication was assessed 6 to 8 weeks after treatment using the urea breath test.

Sponsors and collaborators

Lead sponsor

Zero Helicobacter IGAN Network

Other

Collaborators

  • JDWNRH
  • Japan International Cooperation Agency
  • Khesar Gyalpo University of Medical Sciences of Bhutan
  • Oita University
  • Royal Centre for Disease Control Bhutan

Registry information

Official study title

A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Bhutan

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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