The Effect of Probiotics With Vonoprazan-amoxicillin Dual Therapy on Gut Microbiotain After Helicobacter Pylori Eradication: A Randomized Controlled Trial

KY20221124-08

The purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics

2023-06-01

2023-12-31

2023-12-31

Not yet recruiting

Early phase I

100

Inclusion Criteria: 1. Ages between 18 and 65 years; Sexes eligible for study: both; 2. patients who are diagnosed with Helicobacter pylori; 3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months; 4. voluntary to be involved in the study and written informed consent was obtained from all patients Exclusion Criteria: 1. allergic reactions to the study drugs; 2. patients with peptic ulcer; 3. patients who underwent eradication therapy for Helicobacter pylori during the last six months; 4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment; 5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants; 6. patients who have history of esophageal or gastric surgery; 7. pregnant or lactating women; 8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies; 9. Alcohol abusers

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-02-08