Helicobacter Pylori Infection
Conditions
Brief summary
This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.
Detailed description
This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the treatment of Helicobacter pylori in patients with chronic gastritis. This study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. At the same time, it will provide reference for the reasonable pricing of H.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.
Interventions
DRUGEsomeprazole
20mg bid
DRUGBismuth potassium citrate
0.6g bid
DRUGMetronidazole
0.4g qid
DRUGClarithromycin
0.5g bid
DRUGLevofloxacin
0.5g qd
DRUGAmoxicillin
1g bid
DRUGTetracycline
0.5g qid
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The technicians, who performed culture, antimicrobial susceptibility testing or urea breath test were blinded to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF). * 18-75 years old on the day of signing the ICF. * Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
Exclusion criteria
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. * Subjects or guardians refused to participate in the trial. * Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment. * Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment. * Pregnant or lactating women. * Active peptic ulcer. * allergic to drugs used in the trial. * any other circumstances that are not suitable for recruitment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate of Helicobacter pylori | 6 weeks | Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate of Helicobacter pylori resistant strains | 6 weeks | Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method. |
| Eradication rate of Helicobacter pylori susceptible strains | 6 weeks | Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHong Gao, MD
Fudan University
Outcome results
None listed