NCT05802888

Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy of Different Tetracycline Doses and Frequencies.

Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy: A Multicenter Randomized Non-Inferiority Trial of Different Tetracycline Doses and Frequencies.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The researchers collect H.pylori-positive patients who need rescue therapy from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth 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 and patient compliance of each group.

Detailed description

The researchers collect H.pylori-positive patients who need rescue therapy 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 dose and frequency of tetracycline 500mg tid or qid of bismuth 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 and patient compliance of each group were calculated. According to the dose and frequency of tetracycline, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows: Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Tetracycline 500mg tid	Amoxicillin 1000mg bid +Tetracycline 500mg tid +Bismuth+Esomeprazole 40mg bid
DRUG	Tetracycline 500mg qid	Amoxicillin 1000mg bid +Tetracycline 500mg qid +Bismuth+Esomeprazole 40mg bid

Timeline

• Start date: 2023-03-12
• Primary completion: 2024-06-15
• Completion: 2024-06-15
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: China