Gastrointestinal health
Conditions
Interventions
Placebo group:Amoxicillin 1000mg bid
Clarithromycin 500mg bid
Ribeprazole sodium enteric coated tablets 10mg bid
Potassium bismuth citrate capsules 600mg bid
Placebo once daily, please take before bed
Probiotic intervention group:Amoxicillin 1000mg bid
Clarithromycin 500mg bid
Ribeprazole sodium enteric coated tablets 10mg bid
Potassium bismuth citrate capsules 600mg bid
Lactobacillus plantarum Lp0
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign an informed consent form approved by the ethics committee before the experiment; 2. Subjects who understand and comply with the protocol requirements and agree to participate in all study visits; 3. The subject agrees to use appropriate medical methods for contraception during the study process (excluding medical sterilization status): Medical sterilization status is defined as postmenopausal (at least 12 months of natural cessation), after hysterectomy, after bilateral salpingectomy, and after bilateral oophorectomy. Appropriate medical contraceptive methods include intrauterine devices, physical barriers (male and female condoms), subcutaneous implants, slow-release injectable contraceptives, oral contraceptives, bilateral tubal ligation, and bilateral vas deferens ligation. Suggest using dual contraception to ensure that pregnancy does not occur during the research process; 4. Male and female participants aged between 18 and 65 years old (including 18 and 65 years old); 5. If the subject's 13C/14C urea breath test is positive or the gastric mucosal tissue routine staining is H. polyri positive, the researcher determines that H. polyri eradication treatment is necessary (refer to the Helicobacter pylori eradication indications provided by the Chinese Medical Association's Consumer Chemistry Branch); Only those who meet all the above conditions can be selected.
Exclusion criteria
Exclusion criteria: 1. Individuals who are allergic to any drug ingredients used in this study; 2. Have 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. Individuals who have received Helicobacter pylori eradication treatment; 4. Patients who have received treatment with probiotics, antibiotics, bismuth, PPI, or PCAB within one month before consuming the experimental drug; 5. Individuals with a recent history of severe organic diseases such as gastrointestinal bleeding, obstruction, perforation, and tumors; 6. Subjects who plan to be hospitalized for surgical treatment during the research process; 7. Patients who suffer from serious psychological or mental illnesses that prevent them from expressing themselves normally; 8. Female subjects who are in lactation or have positive pregnancy test results during the screening period or trial process; 9. According to the researcher's judgment, the subject has uncontrolled and unstable liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, blood, central nervous system, or psychiatric diseases, which may affect the safety of the subject or the interpretation of the research results; 10. Other researchers determined that participants were not suitable to participate. Those who meet any of the above conditions shall not be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori infection eradication rate;Impact on gut microbiota (6 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and compliance of adverse reactions;Adverse reaction incidence ;compliance; | — |
Countries
China
Contacts
Public ContactDong Jie
Zhejiang Provincial People's Hospital
Outcome results
None listed