Helicobacter Pylori InfectionNCT07439445
Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication
A study testing Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days in people with Helicobacter Pylori Infection, run by Peking University First Hospital at 1 site in China.
Trial summary
To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2026to 13 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years;
- Positive results for both ¹³C-urea breath test (¹³C-UBT) and fecal polymerase chain reaction (PCR), confirming Helicobacter pylori infection, with a clinical indication for H. pylori eradication as judged by the physician;
- Treatment-naïve individuals with no prior history of H. pylori eradication therapy.
Who cannot join
- Pregnant or lactating women
- Patients with a history of allergy to any drugs used in the eradication regimen
- Patients with severe systemic diseases or malignant tumors
- History of gastric resection surgery
- Recent use of antibiotics or bismuth salts (within 4 weeks), H₂-receptor antagonists, proton pump inhibitors (PPIs), or Potassium-competitive acid blockers(P-CABs) (within 2 weeks).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Meng Li, 18612034366, dr_limeng@163.com
About this study
Official title: Efficacy and Safety of Simplified Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line Helicobacter Pylori Eradication
To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene detection.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 daysDrug
Participants receive vonoprazan 20 mg orally twice daily plus clarithromycin 500 mg orally twice daily for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Vonoprazan 20mg twice a day + clarithromycin 500mg twice a day Receives: Drug: Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of H. pylori
- pylori eradication rate assessed by¹³C-urea breath test at 4 weeks after the completion of treatment.
Measured: 4 weeks after the completion of treatment
Secondary outcomes (2)
incidence of adverse reactions
The incidence of adverse reactions refers to the proportion of participants who experience any adverse reactions related to the study drugs (vonoprazan and clarithromycin) during the 14-day medication period.
Measured: At the end of the 14-day medication period (Day 14)
Compliance
Medication compliance rate (proportion of participants with good compliance, defined as compliance rate ≥ 80%).
Measured: At the end of the 14-day medication period (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start25 Apr 2026
- Primary completion13 Feb 2027 (estimated)
- Study completion13 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihong Wang, Peking University First Hospital
- Investigators
- Weihong Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439445
- Sponsor's protocol ID
- 2026R0051-0002
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Simplified Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT07439445
- Acronym / sponsor ID
- 2026R0051-0002
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 13 Feb 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene detection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 daysVonoprazan 20mg twice a day + clarithromycin 500mg twice a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-70 years;
- Positive results for both ¹³C-urea breath test (¹³C-UBT) and fecal polymerase chain reaction (PCR), confirming Helicobacter pylori infection, with a clinical indication for H. pylori eradication as judged by the physician;
- Treatment-naïve individuals with no prior history of H. pylori eradication therapy.
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Patients with a history of allergy to any drugs used in the eradication regimen
- Patients with severe systemic diseases or malignant tumors
- History of gastric resection surgery
- Recent use of antibiotics or bismuth salts (within 4 weeks), H₂-receptor antagonists, proton pump inhibitors (PPIs), or Potassium-competitive acid blockers(P-CABs) (within 2 weeks).
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 |
|---|---|---|
| Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 daysParticipants receive vonoprazan 20 mg orally twice daily plus clarithromycin 500 mg orally twice daily for 14 consecutive days. | Drug | Experimental |
Primary outcome
Eradication rate of H. pylori
Time frame: 4 weeks after the completion of treatment
H. pylori eradication rate assessed by¹³C-urea breath test at 4 weeks after the completion of treatment.
2 secondary outcomes
incidence of adverse reactions
Time frame: At the end of the 14-day medication period (Day 14)
Compliance
Time frame: At the end of the 14-day medication period (Day 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- 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.
Weihong Wang, MD, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days in people with Helicobacter Pylori Infection, run by Peking University First Hospital at 1 site in China.
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 5 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weihong Wang, MD, PhD (13041171610, wangweihong2581@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of H. pylori (time frame: 4 weeks after the completion of treatment). 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 30 Apr 2026.