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

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Enrolling
Phase 4

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Amoxicillin
Drug: Vonoprazan
Drug: Bismuth Potassium Citrate
Drug: Minocycline,Metronidazole

Study type

Interventional

Funder types

Other

Identifiers

NCT06561698
rjhy20240814

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Dual therapy
Experimental group
Treatment:
Drug: Vonoprazan
Drug: Amoxicillin
Minocycline bismush quadruple therapy
Experimental group
Treatment:
Drug: Minocycline,Metronidazole
Drug: Bismuth Potassium Citrate
Drug: Vonoprazan

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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