H.PyloriNCT07211880
Helicobacter Pylori Infection and Gastric Disease in Bhutan: First Community-Wide, Population-Based Study
A study testing Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin, Upper gastrointestinal endoscopy for the H. pylori and serum pepsinogen positive individuals (high risk group of gastric cancer) and Urea Breath Test for the prevalence of H pylori in people with H.Pylori and Gastric Cancer, run by Zero Helicobacter IGAN Network at 1 site in Bhutan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- H.Pylori, Gastric Cancer, H Pylori Eradication
- What is being tested?
- Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin, Upper gastrointestinal endoscopy for the H. pylori and serum pepsinogen positive individuals (high risk group of gastric cancer) and Urea Breath Test for the prevalence of H pylori
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,043 participants
- Where
- 1 siteBhutan
- Study dates
- 5 Dec 2019to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Bhutan1 site
Khesar Gyalpo University of Medical Sciences of Bhutan
Thimphu, Thimphu District
About this study
Official title: A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Bhutan
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.
Read the 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
- Being tested
- Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin, Upper gastrointestinal endoscopy for the H. pylori and serum pepsinogen positive individuals (high risk group of gastric cancer), Urea Breath Test for the prevalence of H pylori
- Keywords
- H. pylori, gastric cancer, H pylori eradication triple therapy, Bhutan
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole Sodium, Amoxicillin Hydrate, ClarithromycinDrug
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 pyloriDevice
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.)
| Study group | Role | What they receive |
|---|---|---|
| H pylori positive individual | Experimental | H pylori positive individual receiving triple therapy Receives: 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). Receives: Device: Urea Breath Test for the prevalence of H pylori |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of H. pylori
The seroprevalence of H. pylori (IgG ≥10 U/m) as positive for the H pylori
Measured: 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.
Measured: 2 Months
Secondary outcomes (3)
Gastrointestinal endoscopic examination
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.
Measured: 3 months
H pylori eradication therapy
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.
Measured: 3 months
Urea Breath Test (UBT) of H pylori eradication therapy
Success of the H pylori eradication was assessed 6 to 8 weeks after treatment using the urea breath test.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start5 Dec 2019
- Primary completion11 Dec 2020
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H.PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Screening of H pylori and eradication in order to prevent gastric cancer using community-based longitudinal study
- Masking
- None (open label)
- Enrolment
- 1,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zero Helicobacter IGAN Network
- Sponsor type
- University, hospital or other
- Collaborators
- Oita University, Japan International Cooperation Agency, JDWNRH, Khesar Gyalpo University of Medical Sciences of Bhutan, Royal Centre for Disease Control Bhutan
- Responsible party
- Principal investigator, Yumiko Kamogawa, Zero Helicobacter IGAN Network
- Investigators
- Yumiko Kamogawa, M.D., Ph.D., Study director, NPO HIGAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211880
- Sponsor's protocol ID
- PO/2019/076
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Bhutan
- ClinicalTrials.gov ID
- NCT07211880
- Acronym / sponsor ID
- PO/2019/076
- Conditions
- H.Pylori, Gastric Cancer, H Pylori Eradication
- Keywords
- H. pylori, gastric cancer, H pylori eradication triple therapy, Bhutan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,043 participants (actual)
- Lead sponsor
- Zero Helicobacter IGAN NetworkUniversity, hospital or other
- Collaborators
- Oita University, Japan International Cooperation Agency, JDWNRH, Khesar Gyalpo University of Medical Sciences of Bhutan, Royal Centre for Disease Control Bhutan
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Screening of H pylori and eradication in order to prevent gastric cancer using community-based longitudinal study
| Arm | Type | Receives |
|---|---|---|
| H pylori positive individual | Experimental | 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 individual receiving triple therapy |
| H. pylori positive individuals for UBT test | Experimental | Device: Urea Breath Test for the prevalence of H pyloriThe 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). |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- • Both male and female age 12 years and above in the selected communities for H. pylori infection screening
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin7 days therapy | Drug | H pylori positive individual |
| 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). | Diagnostic test | H pylori positive individual |
| Urea Breath Test for the prevalence of H pyloriAfter 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.) | Device | H. pylori positive individuals for UBT test |
Primary outcome
Prevalence of H. pylori
Time frame: 2 months
The seroprevalence of H. pylori (IgG ≥10 U/m) as positive for the H pylori
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.
3 secondary outcomes
Gastrointestinal endoscopic examination
Time frame: 3 months
H pylori eradication therapy
Time frame: 3 months
Urea Breath Test (UBT) of H pylori eradication therapy
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yumiko Kamogawa, M.D., Ph.D. study director
NPO HIGAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rabeprazole Sodium, Amoxicillin Hydrate, Clarithromycin, Upper gastrointestinal endoscopy for the H. pylori and serum pepsinogen positive individuals (high risk group of gastric cancer) and Urea Breath Test for the prevalence of H pylori in people with H.Pylori and Gastric Cancer, run by Zero Helicobacter IGAN Network at 1 site in Bhutan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bhutan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of H. pylori (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.