Helicobacter Pylori Infection Clinical Trial
Official title:
Study on the Effect of Fucoidan Combined With the Eradication Program Containing Vonoprazan on H.Pylori Eradication Rate and Gastrointestinal Flora.
Verified date | December 2023 |
Source | Nanjing First Hospital, Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate whether the eradication rate of H.pylori will be improved when adding fucoidan to the duplex scheme combination of amoxicillin and vonoprazan, and to explore the effect of fucoidan on gastrointestinal flora of patients.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 31, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Age 18-65 years old; 2. Patients diagnosed as HP positive; 3. Patients who have not received HP eradication treatment in the past, or who have failed in the early eradication but have not received eradication treatment within half a year; 4. Voluntarily participate in this trial and sign the informed consent form. Exclusion Criteria: 1. Allergic to the study drug (penicillin allergy, etc.); 2. Patients with chronic gastritis and peptic ulcer; 3. Patients who have received HP eradication treatment within half a year; 4. Antibiotics and bismuth agents were used 4 weeks before the start of the study treatment, and histamine H2 receptor antagonists or PPIs were used 2 weeks before the start of the study treatment; 5. Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants; 6. History of esophageal or gastric surgery; 7. Pregnant and lactating women; 8. Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease; |
Country | Name | City | State |
---|---|---|---|
China | Nanjing First Hospital, Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | compare eradication rates of the two groups by 13C-UBT | Compare the eradication rate of Helicobacter pylori between the fucoidan containing group and the fucoidan free group | 6 weeks | |
Primary | Analysis of intestinal flora difference before and after eradication using 16s rRNA sequencing | Analyze and compare the early and long-term changes of intestinal flora before and after eradication. Explore the effect of fucoidan on intestinal flora of patients receiving eradication treatment. | 6 weeks |
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