Randomized and Controlled Clinical Study of High-dose Dual Therapy With Different Administration Frequencies in the Treatment of Helicobacter Pylori

rjyy20210815

This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

2021-03-30

2023-09-10

2023-09-30

Completed

Early phase I

327

Inclusion Criteria: * Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection Exclusion Criteria: * Pregnant and lactating women; * History of gastrointestinal malignancies; * History of previous subtotal gastrectomy; * Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc; * History of hematological diseases * People who are allergic to drugs; * The guardian or patient refused to join the group; * Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors; * No legal capacity or poor self-knowledge * administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 327, 'type': 'ACTUAL'}}

2023-12-21