A randomised, double-blind, placebo-control trial, to assess the safety and effectiveness of Lactobacillus rhamnosus LRa05 on eradication of Helicobacter pylori

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: 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 drugs; CONDITION: Gastrointestinal health PRIMARY OUTCOME: Helicobacter pylori infection eradication rate; SECONDARY OUTCOME: GRSR;Incidence and compliance of adverse reactions; 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 inde X(BMI) = weight (kg)/height^2 (m^2), and the body mass inde Xis = 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.
Epistemonikos ID: 9d53f58be8832991b6f75ffcf9899aa7b345243c
First added on: Feb 20, 2024