Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication
Phase 4
Completed
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT05049902
- Lead Sponsor
- Shandong University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1300
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 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10-day treatment group Bismuth Potassium Citrate 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 14-day treatment group Bismuth Potassium Citrate 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 10-day treatment group Colloidal Bismuth Pectin 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 14-day treatment group Colloidal Bismuth Pectin 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 10-day treatment group Vonoprazan fumarate 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 14-day treatment group Vonoprazan fumarate 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 10-day treatment group Clarithromycin 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 10-day treatment group Amoxicillin 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 10-day treatment group Tetracycline 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 10-day treatment group Metronidazole 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 14-day treatment group Amoxicillin 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 14-day treatment group Tetracycline 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 14-day treatment group Clarithromycin 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 14-day treatment group Metronidazole 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
- Primary Outcome Measures
Name Time Method Eradication rate Immediately after follow-up check. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.
- Secondary Outcome Measures
Name Time Method Patient compliance Immediately after follow-up check. Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Rate of adverse reactions Immediately after follow-up check. Rate of adverse reactions
Cost-effectiveness index Immediately after follow-up check. Ratio of costs to effectiveness
Trial Locations
- Locations (6)
Maternity and Child Care Health Center of Dezhou
🇨🇳Dezhou, Shandong, China
Heze Municipal 3rd people's hospital
🇨🇳Heze, Shandong, China
Qilu hosipital
🇨🇳Jinan, Shandong, China
PKUCare Luzhong Hospital
🇨🇳Zibo, Shandong, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The People's Hospital of Jimo.Qingdao
🇨🇳Qingdao, China