Keverprazan-Minocycline Dual Therapy vs Bismuth Quadruple Therapy for H. pylori Eradication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 trial compares two regimens for Helicobacter pylori infection. Participants aged 18 to 65 with confirmed infection and no prior eradication therapy will receive either a keverprazan-minocycline dual therapy or a bismuth-based quadruple regimen. The study will evaluate eradication rates, patient adherence, and adverse drug reactions to determine relative safety and effectiveness. Primary outcomes focus on eradication success, while safety and tolerability are also closely monitored. Conducted at Nanjing First Hospital, the trial aims to inform optimal first-line treatment options for H. pylori.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-65 years;
2. Positive H. pylori status confirmed by 13C-urea breath test and no prior history of eradication therapy;
3. Voluntary participation and provision of written informed consent

Exclusion Criteria:

1. Allergy to any study medication (e.g., minocycline, keverprazan, amoxicillin);
2. Confirmed active peptic ulcer disease;
3. Prior history of H. pylori eradication treatment;
4. Use of antibiotics or bismuth agents within 4 weeks before treatment initiation, or use of proton pump inhibitors within 2 weeks;
5. Current use of corticosteroids, nonsteroidal anti-inflammatory drugs, or anticoagulants;
6. History of esophageal or gastric surgery;
7. Pregnancy or lactation;
8. Severe comorbidities, including hepatic, cardiovascular, pulmonary, or renal disease;
9. Alcohol abuse;
10. Gastric mucosa-associated lymphoid tissue lymphoma, malignant tumors, peptic ulcer disease, or bronchial asthma;
11. Concurrent use of specific medications: atazanavir or rilpivirine, tricyclic antidepressants, levodopa, acetaminophen, guaifenesin/dextromethorphan, monoamine oxidase inhibitors, tramadol, or similar agents.

Where it's running

• Nanjing First Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhenyu Zhang
• Email: zzy6565@sina.com
• Phone: 18951670222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.