Gastrointestinal health
Conditions
Interventions
Placebo:Rabeprazole 20mg BID
Levofloxacin: 250mg BID
Metronidazole 400mg BID
Bismuth pectin: 200mg TID
Placebo once daily (oral), 2 hours after drug
Probiotic:Rabeprazole 20mg BID
Levofloxacin: 250mg BID
Metronidazole 400mg BID
Bismuth pectin: 200mg TID
Lactobacillus rhamnosus LRa05 once a day (orally), take it two hours after taking the above dru
Sponsors
Jinshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test; 2) Able to complete the research according to the requirements of the test plan; 3) Subjects (including male subjects) have no family planning and voluntarily take effective contraceptive measures from 14 days before screening to 6 months after the end of the trial; 4) Male and female subjects aged 18 to 65 (including 18 and 65 years old); 5) Male subjects should weigh no less than 50 kg. Female subjects weigh no less than 45 kg. Body mass index (BMI) = weight (kg)/height^2 (m^2), and the body mass index is = 19.0 kg/m^2; 6) Chinese adults who meet one of the following diagnostic criteria for Helicobacter pylori infection: RUT-positive gastric mucosal tissue or 13C/14C-UBT-positive; Only those who meet all the above conditions can be selected.
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to any drug ingredients used in this study; 2) Has a history of alcoholism (drinking more than 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 3) Those who have received Helicobacter pylori eradication therapy; 4) Patients who have received probiotic treatment within 1-3 months before taking the test drug; 5) Those with a recent history of serious organic diseases such as gastrointestinal bleeding, obstruction, perforation, and tumor; 6) Patients with liver disease (transaminase index > 1.5 times the normal value) and kidney disease (creatinine index higher than the normal value); 7) Abnormal stool routine: fecal occult blood (+); 8) Patients who suffer from severe psychological or mental illness, resulting in the inability to express normally; 9) Female subjects are breastfeeding or have positive pregnancy test results during the screening period or test; 10) Subjects judged by other researchers to be unsuitable for participation. Those who meet any of the above conditions shall not be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori infection eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| GRSR;Incidence and compliance of adverse reactions; | — |
Countries
China
Contacts
Public ContactBu Shurui
Jinshan Hospital Affiliated to Fudan University
Outcome results
None listed