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

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Tetracycline; Drug: Colloidal Bismuth Pectin; Drug: Vonoprazan fumarate; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Metronidazole; Drug: Bismuth Potassium Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04901117

2021-SDU-QILU-G001

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 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.

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 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.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-65.
• Patients with H.pylori infection (Positive for any of the following: H.pylori culture, histopathology test, rapid urease test, 13C/14C-urea breath test, stool H.pylori antigen test).
• Patients whose birth place and residence within five years of birth are Shandong Province.
• 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 3 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 whose current residence is not in Shandong Province.
• Patients whose re-check 13C/14C-urea breath test is negative before the start of the test.
• 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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1,300 participants in 2 patient groups

10-day treatment group

Experimental group

Description:

Use the following drug combination option for 10 days. 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. The dosage of each drug is: Amoxicillin (Amoxicillin, United Laboratories Co., Ltd.) 1000mg bid Clarithromycin (Klacid, Abbott S.r.l) 500mg bid Tetracycline 500mg qid Metronidazole400mg qid Bismuth Potassium Citrate (Livzon Pharmaceutical Group Inc.) 220mg bid Colloidal Bismuth Pectin (North China Pharmaceutical Co., Ltd.) 200mg bid Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid

Treatment:

Drug: Vonoprazan fumarate

Drug: Colloidal Bismuth Pectin

Drug: Amoxicillin

Drug: Clarithromycin

Drug: Bismuth Potassium Citrate

Drug: Metronidazole

Drug: Tetracycline

14-day treatment group

Active Comparator group

Description:

Use the following drug combination option for 14 days. 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. The dosage of each drug is: Amoxicillin (Amoxicillin, United Laboratories Co., Ltd.) 1000mg bid Clarithromycin (Klacid, Abbott S.r.l) 500mg bid Tetracycline 500mg qid Metronidazole400mg qid Bismuth Potassium Citrate (Livzon Pharmaceutical Group Inc.) 220mg bid Colloidal Bismuth Pectin (North China Pharmaceutical Co., Ltd.) 200mg bid Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid

Treatment:

Drug: Vonoprazan fumarate

Drug: Colloidal Bismuth Pectin

Drug: Amoxicillin

Drug: Clarithromycin

Drug: Bismuth Potassium Citrate

Drug: Metronidazole

Drug: Tetracycline