Helicobacter pylori Infection
Conditions
Interventions
Group A:Dual Therapy:Rabeprazole (10mg): 20mg bid, 30 minutes before breakfast and dinnerAmoxicillin (0.25g): 1g tid, 30 minutes after three meals
Group B:Dual Therapy:Rabeprazole (10 mg): 20 mg bid, 30 minutes before breakfast and dinnerAmoxicillin (0.25 g): 1 g tid, 30 minutes after three mealsSaccharomyces boulardii sachets (0.25 g): 0.5 g bi
Sponsors
The Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years old, gender unrestricted; 2. Patients with confirmed active H. pylori infection by^14C-UBT or gastric mucosal histopathological examination; 3. Treatment-naïve patients receiving first-line H. pylori eradication therapy; or patients with previous failed eradication therapy or reinfection, who have not received any antibiotics, bismuth-containing agents, or proton pump inhibitors (PPIs) within at least 4 weeks prior to screening. 4. Presence of H. pylori-related symptoms (e.g., epigastric pain, acid reflux, belching), or asymptomatic but willing to receive treatment voluntarily. 5. Able to understand and sign the informed consent form, and committed to taking medications on time, completing follow-up visits and sample collection.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to amoxicillin, rabeprazole, Saccharomyces boulardii, or any of their respective excipients; 2. Complicated with severe gastrointestinal diseases, malignant tumors, or severe cardiac, hepatic or renal complications; 3. Received antibiotics, bismuth preparations, PPIs or probiotic products within the past 4 weeks, or undergone H. pylori eradication therapy within the past 3 months; 4. Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants (e.g., warfarin) or glucocorticoids (prednisone > 10 mg/day); 5. Pregnant or lactating women, or those planning to become pregnant during the study period; 6. Those with mental illness or cognitive impairment who are unable to cooperate with the research process.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H. pylori eradication rate at 4 weeks post-treatment (confirmed by 14C-UBT); | — |
Secondary
| Measure | Time frame |
|---|---|
| H. pylori recurrence rate at 3 months post-treatment;Changes in gut microbiota alpha diversity (e.g., Shannon index), composition, and functional metabolic pathways before and after treatment;Gut microbiota biomarkers associated with eradication success or failure (e.g., specific bacterial genera, short-chain fatty acids);Amoxicillin resistance status prior to treatment;Risk of amoxicillin resistance transmission associated with the treatment regimen;14C-urea breath test prior to treatment;14C-urea breath test at 4 weeks post-treatment;14C-urea breath test at 3 months post-treatment;Stool specimens collected prior to treatment;Stool specimens collected at 4 weeks post-treatment;Stool specimens collected at 3 months post-treatment; | — |
Countries
China
Contacts
Public ContactYang Jie
The Affiliated Hospital of Guizhou Medical University
Outcome results
None listed