NCT07439445 Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication
| NCT ID | NCT07439445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-04-25 |
| Primary Completion | 2027-02-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-04-25 with a primary completion date of 2027-02-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 detection.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-70 years; 2. 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; 3. Treatment-naïve individuals with no prior history of H. pylori eradication therapy. Exclusion Criteria: 1. Pregnant or lactating women 2. Patients with a history of allergy to any drugs used in the eradication regimen 3. Patients with severe systemic diseases or malignant tumors 4. History of gastric resection surgery 5. 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).
Contact & Investigator
Weihong Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT07439445 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07439445 currently recruiting?
Yes, NCT07439445 is actively recruiting participants. Contact the research team at wangweihong2581@163.com for enrollment information.
Where is the NCT07439445 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07439445 clinical trial?
NCT07439445 is sponsored by Peking University First Hospital. The principal investigator is Weihong Wang, MD, PhD at Peking University First Hospital. The trial plans to enroll 70 participants.