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Efficacy and Safety of Minocycline-Vonoprazan Dual Therapy Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Multicenter, Open-Label, Randomized, Non-Inferiority Study

Efficacy and Safety of Minocycline-Vonoprazan Dual Therapy Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Multicenter, Open-Label, Randomized, Non-Inferiority Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122517
Enrollment
Unknown
Registered
2026-04-14
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

14-day minocycline and vonoprazan dual therapy:14-day minocycline and vonoprazan dual therapy
14-day bismuth-containing quadruple therapy:14-day bismuth-containing quadruple therapy

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Individuals who have not undergone prior Hp eradication therapy; 2. Confirmed positive Hp infection via 13C-UBT (limited to Hidewei or 75mg Huagen breath test kits; a breath value >6 is considered positive; patients with breath values within the borderline range are excluded from enrollment); 3. Voluntary participation and signed informed consent. 4. Age range of 18-70 years old, gender not limited.

Exclusion criteria

Exclusion criteria: 1. Previous H. pylori eradication therapy; 2. Severe allergic constitution or allergy to this study drugs; 3. Zollinger-Ellison syndrome, hyperchlorhydria, or history of hyperchlorhydria; 4. Current acute upper gastrointestinal bleeding, presence of more than two peptic ulcers, or ulcers exceeding 0.5 cm in diameter; 5. History of gastric or intestinal resection affecting drug metabolism; 6. Concurrent severe systemic diseases (e.g., cardiovascular, respiratory, gastrointestinal, neurological), malignancy, or severe psychological/psychiatric disorders; 7. Concurrent severe hepatic or renal impairment (ALT and AST <= 1.5 times upper limit of normal; Cr <= upper limit of normal); 8. Use of PPIs or antibiotics within one month prior to screening; 9. Pregnant or lactating women; 10. Participation in other drug or medical device clinical studies within 30 days prior to screening; 11. Other factors deemed by the investigator to make the subject unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
eradication rate of Hp infection;

Secondary

MeasureTime frame
The Outcome of the Gut Microbiome;Incidence of adverse events;Patient compliance;Hp antibiotic resistance rate;

Countries

China

Contacts

Public ContactYin Zhu

The First Affiliated Hospital of Nanchang University

zhuyin27@sina.com+86 13970841464

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026