High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT06561698
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minocycline bismush quadruple therapy Bismuth Potassium Citrate - Minocycline bismush quadruple therapy Minocycline,Metronidazole - Dual therapy Vonoprazan - Dual therapy Amoxicillin - Minocycline bismush quadruple therapy Vonoprazan -
- Primary Outcome Measures
Name Time Method Helicobacter pylori eradication rate Six weeks after completion of therapy Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
- Secondary Outcome Measures
Name Time Method Rate of adverse effects Within 7 days after completion of therapy The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)
Compliance rate Within 7 days after completion of therapy Compliance was defined as poor when they had taken less than 80% of the total medication
Trial Locations
- Locations (10)
Hebi People's Hospital
🇨🇳Hebi, Henan, China
Jiaozuo People's Hospital
🇨🇳Jiaozuo, Henan, China
Luoyang central Hospital
🇨🇳Luoyang, Henan, China
The first people's hospital of ping ding shan
🇨🇳Pingdingshan, Henan, China
Xuchang central Hospital
🇨🇳Xuchang, Henan, China
The Second Affiliated Hospital of Henan University of science and technology
🇨🇳Zhengzhou, Henan, China
Zhengzhou People's Hospital
🇨🇳Zhengzhou, Henan, China
The Third People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Zhoukou Central Hospital
🇨🇳Zhoukou, Henan, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China