Helicobacter pylori
Conditions
Interventions
A Group Precision Treatment Group:Patients were grouped according to the results of drug resistance in stool culture
Antibiotic resistance ? A1 group tigoraxan + amoxicillin high dose group
Antibiotic
Group A2b sensitive to levofloxacin (levofloxacin 200mg bid+ amoxicillin 1000mg bid+ tigolaxan 50mg bid)
Group B empirical treatment group:High-dose dual therapy of ticorrasan and amoxicillin
Observation group:None
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants in the cohort study: 1. Families with at least 2 family members, there is no upper limit on the number of people in the same family. Family composition may include couples raising one child, multiple couples of different generations, or single-parent families; 2. Family members should live together for a long time; 3. If they are willing to cooperate with this study, they or their guardians sign the informed consent. The subjects of the RCT experiment 1. Age: 18-70 years old, male or female; 2. Patients were Helicobacter pylori positive by urea breath test or fecal antigen test; 3. Patients with initial treatment of Helicobacter pylori; 4. Patients or their legal representatives signed informed consent, understood and agreed to follow the study requirements.
Exclusion criteria
Exclusion criteria: Subjects of cohort study 1. To ensure the accuracy of 13C-UBT and avoid false negative results, if any member has taken antibiotics, bismuth, and traditional Chinese medicine with antibacterial effect in the past month, and Proton Pump Inhibitor (PPI), H2 receptor antagonist and other drugs in the past two weeks, Or have received Hp treatment in the past three months, the family will be excluded; 2. Living alone; 3. Patients with severe heart, liver, kidney dysfunction, severe neuropathy or mental disease; 4. Sensitive population such as pregnant women; 5. Subjects who were deemed unsuitable for the study by the investigator.? The subjects of the RCT experiment Exclusion criteria: 1. Use of PPI, potassium competitive acid blockers, antibiotics, H2 receptor antagonists, bismuth, probiotics, traditional Chinese medicine and other drugs related to eradication of Helicobacter pylori within four weeks before treatment; 2. Pregnant or lactating women, patients who planned to have children during the study period; 3. Taking non-steroidal anti-inflammatory drugs, adrenocortical steroids, anticoagulants and alcohol during treatment; 4. Patients allergic to the drugs used in this study; 5. Severe underlying diseases: hepatic insufficiency (AST or ALT >3 times the upper limit of normal), renal impairment (creatinine level >=2.0 mg/dL or glomerular filtration rate =75%), mental illness, etc.; 6. Patients with previous gastric or esophageal surgery; 7. Participated in other drug studies within the previous three months; 8. It was difficult to complete the follow-up or there were other factors affecting compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of H. pylori eradication rates;Microecological impact assessment of alpha diversity;Digital evaluation of tongue image (quantitative scoring of tongue texture and coating characteristics; dynamic changes);Overall infection rate (Observational study);Stratified infection rate (region, age, gender, ethnicity)(Observational study);Overall drug resistance rate (Observational study);Primary drug resistance rate (Observational study);Acquired drug resistance rate (Observational study);CYP2C19 metabolic phenotype distribution (EM/IM/PM) (Observational study); | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse events;Discontinuation rate due to AE;Infection density (Observational study);Family clustering index (Observational study);Single resistance spectrum (Observational study);Dual resistance spectrum;Distribution of resistance genotypes;Virulence gene combination patterns;Ethnic differences;Gender differences; | — |
Countries
China
Contacts
Public ContactDekui Zhang
Lanzhou University Second Hospita
Outcome results
None listed