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

NCT07757919 | Not Yet Recruiting Phase 4

• 1 other identifier: KYLL-2026-06-012-1
• Study Type: interventional
• Target: 492
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• ¹³C-urea breath test

  6 weeks after the end of treatment

Secondary Outcomes (2)

• Adverse event rate

  Within 1 week after the end of treatment

• Participant compliance

  Within 1 week after the end of treatment

Study Arms (3)

14-day vonoprazan-amoxicillin dual therapy regimen

ACTIVE COMPARATOR

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-Amoxicillin Dual Therapy

14-day vonoprazan-tetracycline dual therapy regimen

ACTIVE COMPARATOR

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

Drug: Vonoprazan-Tetracycline Dual Therapy

14-day vonoprazan-minocycline dual therapy regimen

EXPERIMENTAL

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

Drug: Vonoprazan-Minocycline Dual Therapy

Interventions

Vonoprazan-Amoxicillin Dual Therapy DRUG

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

14-day vonoprazan-amoxicillin dual therapy regimen

Vonoprazan-Tetracycline Dual Therapy DRUG

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

14-day vonoprazan-tetracycline dual therapy regimen

Vonoprazan-Minocycline Dual Therapy DRUG

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

14-day vonoprazan-minocycline dual therapy regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years, male or female.
• Helicobacter pylori-infected patients with positive ¹³C/¹⁴C urea breath test, and at least one positive result among the following three tests: Rapid Urease Test; Histopathological examination of gastric mucosal biopsy specimens; Stool Hp antigen test.
• No prior history of Helicobacter pylori eradication therapy.

You may not qualify if:

• Severe underlying diseases, such as hepatic insufficiency, renal insufficiency, malignant tumors, etc.
• Active gastrointestinal bleeding.
• History of upper gastrointestinal surgery.
• History of allergy to study medications.
• Use of antibiotics or bismuth agents within 1 month, or acid-suppressive agents within 2 weeks.
• Pregnant or lactating women.
• Presence of other behaviors that may increase disease risks, such as heavy alcohol consumption, drug abuse, etc.
• Participation in other clinical trials within 3 months.
• Subjects unable or unwilling to provide written informed consent.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Central Study Contacts

Li

CONTACT

+86 18560089751; lyynqj@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share