Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Bismuth-containing quadruple regimen
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.
Interventions
DRUGAmoxicillin
Use according to the drug combination options selected by each center.
DRUGClarithromycin
Use according to the drug combination options selected by each center.
DRUGTetracycline
Use according to the drug combination options selected by each center.
DRUGMetronidazole
Use according to the drug combination options selected by each center.
DRUGBismuth Potassium Citrate
Use according to the drug combination options selected by each center.
Use according to the drug combination options selected by each center.
Use according to the drug combination options selected by each center.
Sponsors
The Affiliated Hospital of Qingdao University
The People's Hospital of Guangrao
Weihai Municipal Hospital
Shandong Province Third hospital
Taian City Central Hospital
Jining No.2 People's Hospital
Maternity and Child Care Health Center of Dezhou
Zoucheng People's Hospital
Heze Municipal 3rd people's hospital
Yuncheng Chengxin Hospital
Peking University Care Luzhong Hospital
Qihe County City Hospital
Weifang People's Hospital
Qilu Hospital of Shandong University
Shandong Electric Power Central Hospital
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This trial is a multi-center, open-label, non-inferiority, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 90% of the study medications and complete follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse reactions | Immediately after follow-up check. | Rate of adverse reactions |
| 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. |
| Cost-effectiveness index | Immediately after follow-up check. | Ratio of costs to effectiveness |
Countries
China
Contacts
Primary ContactXiuli Zuo, MD,PhD
Backup ContactXiuli Zuo, MD,PhD
Outcome results
None listed