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

Shandong University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Tetracycline tid; Drug: Bismuth Potassium Citrate; Drug: Esomeprazole 20mg; Drug: Amoxicillin; Drug: Colloidal Bismuth Pectin; Drug: Tetracycline qid

Study type: Interventional

Funder types: Other

Identifiers

NCT05431075

2022-SDU-QILU-G004

Details and patient eligibility

About

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.

Full 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

Enrollment: 406 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-70.
• Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
• Patients who have never received H. pylori eradication treatment.

Exclusion criteria

• Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
• Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
• Patients with active gastrointestinal bleeding.
• Patients with a history of upper gastrointestinal surgery.
• Patients allergic to treatment drugs.
• Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
• Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
• Patients who are unwilling or incapable to provide informed consents.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

Tid group

Experimental group

Description:

Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid

Treatment:

Drug: Colloidal Bismuth Pectin

Drug: Amoxicillin

Drug: Tetracycline tid

Drug: Bismuth Potassium Citrate

Drug: Esomeprazole 20mg

Qid group

Active Comparator group

Description:

Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid

Treatment:

Drug: Colloidal Bismuth Pectin

Drug: Tetracycline qid

Drug: Amoxicillin

Drug: Bismuth Potassium Citrate

Drug: Esomeprazole 20mg