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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days; Drug: Vonoprazan+Amoxicillin; Drug: Vonoprazan+doxycycline

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 810
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenyu Zhang; Phone Number: 18951670222; Email: zhangzhenyu808@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A Bismuth quadruple; Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth, treatment course 14 days	Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days; Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.; Other Names: Doxycycline-based Bismuth Quadruple Therapy
Experimental: Group B Amoxicillin Dual therapy; Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid , treatment course 14 days	Drug: Vonoprazan+Amoxicillin; Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.; Other Names: Vonoprazan+Amoxicillin Dual therapy
Experimental: Group C doxycycline Dual therapy; Vonoprazan 20 mg, bid +doxycycline 0.1 g, bid，treatment course 14 days	Drug: Vonoprazan+doxycycline; Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.; Other Names: Vonoprazan+doxycycline Dual therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HP eradication rate	The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT	4-6 weeks after the end of the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance	Rate of drug consumption during the treatment period of the subjects	Within 3 days after the end of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Security observations	Adverse drug reactions	Within 3 days after the end of treatment

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Helicobacter Pylori Infection; Dual therapy
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Antacids; Doxycycline; Amoxicillin; Bismuth
• Other Study ID Numbers: KY20240123-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No