Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, tetracycline, 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 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
Interventions
DRUGAmoxicillin
Included in quadruple eradication medication.
DRUGTetracycline tid
Included in quadruple eradication medication.
DRUGTetracycline qid
Included in quadruple eradication medication.
DRUGBismuth Potassium Citrate
Included in quadruple eradication medication.
Included in quadruple eradication medication.
Included in quadruple eradication medication.
Sponsors
Peking University Care Luzhong Hospital
Yuncheng Traditional Chinese Medicine Hospital
Taierzhuang District People's Hospital
Zhengzhou Central Hospital
Zibo 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 70 Years
Healthy volunteers
No
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.
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
Outcome results
None listed