Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Qā¦ (NCT06603688) | Clinical Trial Compass
UnknownPhase 4
Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.
China548 participantsStarted 2023-11-20
Plain-language summary
The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.
The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Age between 18\~70,both gender.
ā. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
ā. Patients are willing to receive eradication treatment.
ā. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
Exclusion criteria
ā. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
ā. Patients with contraindications or allergies to the study drug.
ā. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
ā. 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).