Helicobacter pylori infection
Conditions
Interventions
intervention group:Keaprazole-based quadruple therapy combined with Saccharomyces boulardii Sachets:
Metronidazole 400 mg tid, Amoxicillin 1 g bid, Keaprazole 20 mg bid, Bismuth Potassium Citrate 220
control group:Keaprazole-based quadruple therapy :
Metronidazole 400 mg tid, Amoxicillin 1 g bid, Keaprazole 20 mg bid, Bismuth Potassium Citrate 220 mg bid
Sponsors
The First People's Hospital of Anning
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 60–80 years of either gender diagnosed with chronic gastritis (with or without atrophy and intestinal metaplasia) in line with the diagnostic criteria specified in the Chinese Expert Consensus on Chronic Gastritis in the Elderly; 2. Subjects with positive ¹³C/¹4C urea breath test results who receive anti-H. pylori eradication therapy for the first time; 3. Subjects have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Complicated with other severe gastrointestinal diseases, such as inflammatory bowel disease, gastric cancer, etc.; 2. Complicated with severe hepatic or renal dysfunction (AST/ALT > 2×upper limit of normal [ULN], Scr > 1.5×ULN), severe cardiac diseases (e.g., heart failure, severe arrhythmia), hematological disorders (e.g., anemia, thrombocytopenia, leukopenia), and other serious systemic illnesses; 3. Patients with known hypersensitivity to bismuth agents, antibiotics, proton pump inhibitors (PPIs) or other study-related medicines; 4. Administration of antifungals, H2-receptor antagonists (H2RAs), PPIs or potassium-competitive acid blockers (P-CABs) within 2 weeks prior to enrollment; use of bismuth preparations, antibiotics (including traditional Chinese medicines with antibacterial activity) or probiotic products (including probiotic-containing foods such as yogurts and probiotic beverages) within 4 weeks before enrollment; 5. Other conditions judged inappropriate for enrollment by investigators, including psychiatric disorders with impaired cognitive function unable to comply with study medication or follow-up visits per investigator’s assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori Eradication Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom Rating Scale, GSRS;Incidence of Adverse Events; | — |
Countries
China
Contacts
Public ContactHuang Chuang
The First People's Hospital of Anning
Outcome results
None listed