NCT05431075

Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment: A Multicenter Randomized Clinical Trial of Different Tetracycline Doses and Frequencies.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 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 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, 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 dose and frequency of tetracycline 500mg tid or qid 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 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 20mg bid Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Amoxicillin	Included in quadruple eradication medication.
DRUG	Tetracycline tid	Included in quadruple eradication medication.
DRUG	Tetracycline qid	Included in quadruple eradication medication.
DRUG	Bismuth Potassium Citrate	Included in quadruple eradication medication.
DRUG	Colloidal Bismuth Pectin	Included in quadruple eradication medication.
DRUG	Esomeprazole 20mg	Included in quadruple eradication medication.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-06-24
• Last updated: 2024-03-27

Locations

6 sites across 1 country: China