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NCT Number: NCT07757919

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

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

Primary outcomes

  1. ¹³C-urea breath test

    Time frame: 6 weeks after the end of treatment

Secondary outcomes

  1. Adverse event rate

    Time frame: Within 1 week after the end of treatment

  2. Participant compliance

    Time frame: Within 1 week after the end of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Efficacy and Safety of 14-Day Vonoprazan-Minocycline Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Non-Inferiority Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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