Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study.

Nanjing Medical University

Status: Not yet enrolling

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Vonoprazan+Amoxicillin; Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days; Drug: Vonoprazan+doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT06412588

KY20240123-18

Details and patient eligibility

About

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Full description

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Enrollment: 810 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18-65 years old;
2. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
3. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
4. Voluntarily join this trial and sign the informed consent form.

Exclusion criteria

1. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
2. Patients with confirmed active peptic ulcer;
3. Patients who have received Helicobacter pylori eradication therapy within half a year;
4. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
5. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
6. History of esophageal or gastric surgery;
7. Pregnant or lactating women;
8. Alcoholism
9. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
10. Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;
11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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810 participants in 3 patient groups

Group A Bismuth quadruple

Active Comparator group

Description:

Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth, treatment course 14 days

Treatment:

Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days

Group B Amoxicillin Dual therapy

Experimental group

Description:

Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid , treatment course 14 days

Treatment:

Drug: Vonoprazan+Amoxicillin

Group C doxycycline Dual therapy

Experimental group

Description:

Vonoprazan 20 mg, bid +doxycycline 0.1 g, bid，treatment course 14 days

Treatment:

Drug: Vonoprazan+doxycycline