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Study on the efficacy and safety of the dual therapy of vonoprazan combined with minocycline and the quadruple therapy of bismuth based on PPI for eradicating Helicobacter pylori infection: A prospective randomized controlled clinical study

Study on the efficacy and safety of the dual therapy of vonoprazan combined with minocycline and the quadruple therapy of bismuth based on PPI for eradicating Helicobacter pylori infection: A prospective randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108446
Enrollment
Unknown
Registered
2025-08-29
Start date
2025-09-05
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Helicobacter pylori infection

Interventions

Group A:Take 20mg of vonoprazan orally, twice daily + 100mg of minocycline orally, twice daily. The treatment course lasts for 14 days.
Group B:Take esomeprazole 20mg orally, twice a day + minocycline 100mg, twice a day + amoxicillin 1000mg, twice a day + colloidal bismuth subcitrate 200mg, twice a day. The treatment course for all is

Sponsors

Sir Run Run Hospital, Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age range: 18 - 75 years old; (2) Patients who tested positive through 13C or 14C breath test and have not received eradication treatment; (3) Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Allergic to the studied drugs (such as minocycline, vonoprazan, etc.); (2) Patients who have undergone Helicobacter pylori eradication treatment; (3) Those who used antibiotics, bismuth agents, or H2 receptor antagonists or PPI within 4 weeks before starting the study treatment, and took probiotics within the last 2 weeks; (4) Using adrenal corticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants; (5) History of esophageal or gastric surgery; (6) Pregnant women and lactating women; (7) Having severe comorbidities, such as liver diseases, cardiovascular diseases, lung diseases, kidney diseases; (8) Heavy alcohol consumption; (9) Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

Design outcomes

Primary

MeasureTime frame
The eradication rate of Helicobacter pylori infection;The effectiveness of eradication of Helicobacter pylori infection ;Changes in the diversity of gastric mucosal microbiota after eradication of Helicobacter pylori infection;Changes in the diversity of intestinal microbiota after eradication of Helicobacter pylori infection;—

Secondary

MeasureTime frame
The compliance of patients with eradication of Helicobacter pylori infection ;Drug adverse reactions;—

Countries

China

Contacts

Public ContactPengpeng Cai

Sir Run Run Hospital, Nanjing Medical University

ppcai@njmu.edu.cn+86 151 5186 4596

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026