Helicobacter Pylori Infection Clinical Trial
Official title:
Helicobacter Pylori Eradication and Follow-up in Zhongshan Hospital
This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.
Status | Recruiting |
Enrollment | 4447 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF). - 18-75 years old on the day of signing the ICF. - Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test. Exclusion Criteria: - Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. - Subjects or guardians refused to participate in the trial. - Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment. - Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment. - Pregnant or lactating women. - Active peptic ulcer. - allergic to drugs used in the trial. - any other circumstances that are not suitable for recruitment. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adherence rate | The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication. | 2 weeks during therapy | |
Other | Frequency of adverse events | Any possible adverse events during the 14-day treatment period were recorded. | 2 weeks during therapy | |
Primary | Eradication rate of Helicobacter pylori | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). | 6 weeks | |
Secondary | Eradication rate of Helicobacter pylori resistant strains | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method. | 6 weeks | |
Secondary | Eradication rate of Helicobacter pylori susceptible strains | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method. | 6 weeks |
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