Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacte… (NCT06514274) | Clinical Trial Compass
CompletedPhase 4
Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication
China558 participantsStarted 2024-09-20
Plain-language summary
The purpose of this study was to evaluate the efficacy and safety of the triple therapy of berberine hydrochloride, vonorasan and amoxicillin for the primary eradication of Helicobacter pylori.It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Who can participate
Age range17 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age between 18\~70,both gender.
✓. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
✓. Patients are willing to receive eradication treatment.
✓. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
Exclusion criteria
✕. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
✕. Patients with contraindications or allergies to the study drug.
✕. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
✕. Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).