High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vonoprazan, Amoxicillin, Bismuth Potassium Citrate, Minocycline,Metronidazole.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.
Interventions
- Drug Vonoprazan
Potassium competitive acid blocker - Drug Amoxicillin
Antibiotics for H. pylori eradication - Drug Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect - Drug Minocycline,Metronidazole
Antibiotics for H. pylori eradication
Primary outcome measures
- Helicobacter pylori eradication rate [Time frame: Six weeks after completion of therapy]
Secondary outcome measures (2)
- Rate of adverse effects [Time frame: Within 7 days after completion of therapy]
- Compliance rate [Time frame: Within 7 days after completion of therapy]
Eligibility criteria
Inclusion criteria
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection
Exclusion criteria
- Pregnant and lactating women;
- History of gastrointestinal malignancies;
- History of previous subtotal gastrectomy;
- Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
- History of hematological diseases
- People who are allergic to drugs;
- The guardian or patient refused to join the group;
- Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
- No legal capacity or poor self-knowledge
- administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 10 centers
- Hebi People's Hospital — Hebi
- Jiaozuo People's Hospital — Jiaozuo
- Luoyang central Hospital — Luoyang
- The first people's hospital of ping ding shan — Pingdingshan
- Xuchang central Hospital — Xuchang
- The Second Affiliated Hospital of Henan University of science and technology — Zhengzhou
- The Third People's Hospital of Zhengzhou — Zhengzhou
- Zhengzhou People's Hospital — Zhengzhou
- … and 2 more centers
Identifiers
NCT: NCT06561698 · rjhy20240814