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Efficacy and Safety of 14-Day Vonoprazan-Minocycline Dual Therapy for Helicobacter Pylori Eradication

NCT07757919 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2026-08-11

No results posted yet for this study

Summary

Investigators will enroll treatment-naïve H. pylori-positive patients according to the inclusion and exclusion criteria in the trial. After obtaining written informed consent, investigators will open envelopes labeled with corresponding subject numbers in the order of subject enrollment to determine group allocation. Subjects will receive interventions according to their assigned regimens: the 14-day vonoprazan-amoxicillin dual therapy regimen, the 14-day vonoprazan-tetracycline dual therapy regimen, or the 14-day vonoprazan-minocycline dual therapy regimen.

Meanwhile, investigators will complete the case report forms (CRFs) to record subjects' basic demographic information and risk factors for eradication failure. Subjects will be asked to fill out patient diaries to document medication administration and adverse reactions. After trial initiation, investigators will follow up with subjects via telephone or WeChat and collect patient diaries, summarize medication status and adverse reactions during treatment, and assess subject compliance.

Six weeks after the end of treatment, subjects will undergo a repeat ¹³C-urea breath test. Investigators will record treatment outcomes and re-examination results, finalize the case report forms, and upload photographs of original examination documents.

After all subjects finish the trial, the eradication rate, incidence of adverse events and subject compliance in each group will be calculated. Statistical analyses will be performed to compare demographic characteristics and risk factors between patients with eradication success and eradication failure. The findings will provide evidence for the selection of H. pylori eradication regimens.

Conditions

  • HELICOBACTER PYLORI INFECTIONS

Interventions

DRUG

Vonoprazan-Amoxicillin Dual Therapy

Medication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Amoxicillin Capsules: 4 capsules (0.25 g each) three times daily, taken immediately after meals. Treatment duration:14 days

DRUG

Vonoprazan-Tetracycline Dual Therapy

Medication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Tetracycline Capsules: 2 capsules (0.25 g each) three times daily, taken immediately after meals. Treatment duration:14 days

DRUG

Vonoprazan-Minocycline Dual Therapy

Medication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Minocycline Hydrochloride Capsules: 2 capsules (50 mg each) twice daily, taken immediately after meals. Treatment duration:14 days

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-11-30
Completion
2027-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757919 on ClinicalTrials.gov