RecruitingPhase 4NCT06561698

High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

200 participants

Start Date

Aug 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • Ability and willingness to participate in the study and to sign and give informed consent
  • Confirmed H. pylori infection

Exclusion Criteria10

  • 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

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Interventions

DRUGVonoprazan

Potassium competitive acid blocker

DRUGAmoxicillin

Antibiotics for H. pylori eradication

DRUGBismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

DRUGMinocycline,Metronidazole

Antibiotics for H. pylori eradication


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

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Zhengzhou People's Hospital

Zhengzhou, Henan, China

Zhoukou Central Hospital

Zhoukou, Henan, China

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

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NCT06561698


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