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Efficacy and Safety of Doxycycline Combined with Vonoprazan in the Treatment of Helicobacter pylori Infection: A Multicenter, Non-Inferiority, Randomized Controlled Trial

Efficacy and Safety of Doxycycline Combined with Vonoprazan in the Treatment of Helicobacter pylori Infection: A Multicenter, Non-Inferiority, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098843
Enrollment
Unknown
Registered
2025-03-14
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Helicobacter pylori infection

Interventions

Experimental group:Vonoprazan 20 mg bid and doxycycline 100 mg bid for 14 days
Control group:Vonoprazan 20 mg bid, amoxicillin 1000 mg tid for 14 days

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18-70 years old, male or female; (2) Patients with confirmed Hp infection: treatment-naïve patients with positive urea breath test (13C/14C); (3) Patients who have failed to be treated with traditional bismuth quadruple therapy in the past and have had no more than 2 treatments in the past. (4) The patient or his/her legal representative signs the informed consent form, understands and agrees to follow the requirements of the study.

Exclusion criteria

Exclusion criteria: (1) Patients who have used antacids, bismuth, antibiotics, probiotics and other drugs that may affect the test results in the past 4 weeks; (2) Patients with organic lesions such as digestive tract tumors and tumors in other parts, patients with bleeding tendency or bleeding in gastric ulcer in the past 4 weeks, and patients who have undergone gastric surgery; (3) Serious diseases that interfere with the test results: such as severe heart, lung, blood, endocrine diseases, liver and kidney insufficiency; (4) Patients who are allergic to the drugs used in this study; (5) Pregnant women, lactating women, and women who are trying to conceive recently; (6) Patients who have had previous gastric and esophageal surgery; (7) Participated in other drug studies within the previous three months; (8) Difficulty in completing follow-up or the presence of other factors affecting compliance.

Design outcomes

Primary

MeasureTime frame
Comparison of helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Comparison of incidence of adverse reactions;Comparison of compliance;Factors influencing eradication rate;

Countries

China

Contacts

Public ContactDekui Zhang

Lanzhou University Second Hospita

sczdk1972@163.com+86 139 0931 8616

Outcome results

None listed

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