NCT04901117

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Multicenter Randomized Clinical Trial of 10 and 14 Days

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Detailed description

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results. After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated. According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows: Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Amoxicillin	Use according to the drug combination options selected by each center.
DRUG	Clarithromycin	Use according to the drug combination options selected by each center.
DRUG	Tetracycline	Use according to the drug combination options selected by each center.
DRUG	Metronidazole	Use according to the drug combination options selected by each center.
DRUG	Bismuth Potassium Citrate	Use according to the drug combination options selected by each center.
DRUG	Colloidal Bismuth Pectin	Use according to the drug combination options selected by each center.
DRUG	Vonoprazan fumarate	Use according to the drug combination options selected by each center.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-01
• Completion: 2023-08-01
• First posted: 2021-05-25
• Last updated: 2021-05-25

Locations

1 site across 1 country: China