helicobacter pylori
Conditions
Interventions
Experimental Group:14-day dual regimen with Tegoprazan (Tegoprazan 50 mg bid + amoxicillin 1 g TID)
control group:14-day bismuth containing quadruple therapy (Esomeprazole 20 mg bid + amoxicillin 1 g bid + Furazolidone 100 mg bid + bismuth potassium citrate 220 mg bid)
Sponsors
The Eighth Affiliated Hospital,Sun Yet-san University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years; 2. Adult subjects who voluntarily signed written informed consent approved by the ethics committee to consent to participate in this study before the start of any study procedure; 3. Subjects who can understand and comply with the protocol requirements and agree to attend all study visits; 4. During the screening phase, patients who were Hp positive and required Hp eradication therapy as judged by the investigator (see Table 1 for H. pylori eradication indications), and patients who had failed Hp eradication for the first time; 5. HP-positive patients were defined as those who were tested positive by C13 or C14 breath test, and the first eradication failure was defined as those who were still tested positive by C13 or C14 breath test 1 month after anti-Hp treatment. 6. Participants agreed to use appropriate medical methods of contraception (except medically sterilized status) during the study.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical studies within 4 weeks before screening; 2. Pregnant or lactating women; 3. Known allergy to ticorrazan, esomeprazole, penicillins or other beta-lactams, macrolide antibiotics, nitrofuran antibiotics, or bismuth (including any relevant adjuvants). If skin sensitivity testing (skin testing) was required, it was performed at visit 1 according to routine medical practice. 4. Participants had a history of drug (including but not limited to opioids) abuse or alcohol abuse (> 14 units of alcohol per week, 1 unit of alcohol ˜360mL of approximately 5% beer or 45 ml of approximately 40% spirits or 150 ml of approximately 12% wine) in the year before the screening visit; 5. The subjects had Zolie-Ellison syndrome, gastric acid hypersecretion, or a history of gastric acid hypersecretion; 6. The subject has undergone previous surgery or operation that may affect gastric acid secretion or drug absorption, such as subtotal gastrectomy, total gastrectomy, vagotomy, intestinal resection, etc. Simple surgery for perforation, appendectomy, cholecystectomy, and endoscopic resection of benign tumors are acceptable. 7. "Warning" symptoms such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia that might indicate the presence of a malignant GI lesion, unless a malignant lesion was ruled out by endoscopy; 8. A history of malignancy within 5 years before screening (participants were allowed to participate if they had been cured of skin basal cell carcinoma or cervical carcinoma in situ); 9. Subjects who could not undergo upper gastrointestinal endoscopy; 10. Upper gastrointestinal endoscopy showed acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric or duodenal mucosal injury; 11. According to the investigator's judgment, the subject has uncontrolled and unstable liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, hematological, central nervous system or mental diseases, etc., and participating in the study may affect the safety of the subject or the interpretation of the study results; 12. Subjects who plan to be hospitalized for surgical treatment during the study; 13. H2-receptor antagonist or PPI use within 14 days prior to screening 13C-urea breath test; During the screening period, antibiotics, bismuth and some traditional Chinese medicine with antibacterial effect were taken within 28 days before 13C-urea breath test; 14. Abnormal laboratory test results at screening in any of the following:AST > upper limit of normal (ULN); ALT > Upper limit of normal (ULN); Total bilirubin > ULN; creatinine > 1.5 times ULN; 15. The subjects had clinically significant abnormal electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contractions (PVC), second degree or above atrioventricular block, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hp eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| intestinal microecology;adverse reactions;Helicobacter pylori drug sensitive; | — |
Countries
China
Contacts
Public ContactHonglei Chen
The Eighth Affiliated Hospital, Sun Yet-san University
Outcome results
None listed