The Efficacy of 10-day and 14-day Bismuth-based Quadruple Therapy in First-line H. Pylori Eradication (Bsm10)
Helicobacter Pylori Infection, Dysbiosis, Probiotics
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection
Eligibility Criteria
Inclusion Criteria:
- Patients who are > 18 years
- Receive gastroscopy because of dyspepsia, acid regurgitation, melena, hematemesis, or others
Exclusion Criteria:
- Bleeding diathesis,
- Major organic diseases
- Malignancy
- Diseases treated with chemotherapy within one month
- Diseases treated with steroids within one month
- Diseases treated with antibiotics within one month,
- Users of aspirin within four weeks before enrollment
- Users of nonsteroidal anti-inflammatory drugs within four weeks before enrollment
- Users of cyclooxygenase-2 selective inhibitors within four weeks before enrollment
- History of H. pylori eradication
- Ingest probiotics or probiotics-containing yogurt with a frequency of >= twice per week one month prior to enrollment
Sites / Locations
- Helicobacter pylori study group, National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
No Intervention
Active Comparator
No Intervention
The 14-day bismuth-based quadruple therapy group
The 10-day bismuth-based quadruple therapy group
The non-H. pylori-infected control
The probiotic therapy group
The non-probiotic control group
The patients receive a 14-day course of the bismuth-based quadruple therapy, including esomeprazole (Nexium 40 mg) 1 tab twice a day, bismuth subcitrate (dibismuth trioxide) (KCB F.C. 120 mg) 1 tab four times a day, metronidazole (Flagyl 250 mg) 2 tab thrice a day, and tetracycline (250 mg) 2 tab four times a day.
The patients receive a 10-day course of the bismuth-based quadruple therapy, including esomeprazole (Nexium 40 mg) 1 tab twice a day, bismuth subcitrate (dibismuth trioxide) (KCB F.C. 120 mg) 1 tab four times a day, metronidazole (Flagyl 250 mg) 2 tab thrice a day, and tetracycline (250 mg) 2 tab four times a day.
Age- and sex-matched patients who do not have H. pylori infection by endoscopic gastric biopsy are enrolled as the non-H. pylori-infected control.
The patients who still have depletion of gut F. prausnitzii 12 months after H. pylori eradication are enrolled into the probiotic supplement trial. They are randomized to the probiotic therapy group ingesting probiotic powder twice daily for 24 weeks. The probiotic powder is named as "President AB powder", which contains an approximately equal mixture of Lactobacillus acidophilus and Bifidobacterium lactis Bb12 at a concentration of >= 10E9 CFU/mL (President Corp., Tainan, Taiwan).
The patients who still have depletion of gut F. prausnitzii 12 months after H. pylori eradication are enrolled into the probiotic supplement trial. They are randomized to the non-probiotic control therapy and they do not ingest probiotic powder.