Helicobacter Pylori Infection, Intestinal Bacteria Flora Disturbance
Conditions
Keywords
Helicobacter Pylori Infection, Eradication treatment, Amoxicillin, vonoprazan, Fucoidan, Intestinal flora
Brief summary
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.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 60 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg TID, fucoidan 1000mg bid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg TID for 14 days. On the 10th and 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 44th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.
Interventions
BIOLOGICALAmoxicillin combined with vonoprazan and fucoidan
Fucoidan was used in combination with amoxicillin and vonoprazan. The purpose of this study was to explore the effect of fucoidan on the eradication rate of Helicobacter pylori and the intestinal flora of subjects.
OTHERAmoxicillin combined with vonoprazan
Amoxicillin and vonoprazan were used as the study control group
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compare eradication rates of the two groups by 13C-UBT | 6 weeks | Compare the eradication rate of Helicobacter pylori between the fucoidan containing group and the fucoidan free group |
| Analysis of intestinal flora difference before and after eradication using 16s rRNA sequencing | 6 weeks | 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. |
Countries
China
Outcome results
None listed