Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatment methods to help people get rid of a bacteria called Helicobacter pylori, which can cause stomach problems. The study is comparing a new treatment called Tegoprazan combined with amoxicillin to a traditional treatment known as bismuth quadruple therapy, which includes a medication called furazolidone. The goal is to see which treatment works better at eliminating the bacteria, how well patients stick to their treatment plans, and if there are any side effects from the medications.

To participate in this trial, you need to be between 18 and 65 years old and have tested positive for Helicobacter pylori without having received treatment before, or you may have tried treatment in the past but it didn’t work. However, there are some people who cannot participate, such as those with certain allergies, active stomach ulcers, or serious health issues like liver or heart disease. If you join the study, you can expect to receive one of the two treatments and be monitored for how well it works and any side effects you may experience. This study is not yet recruiting participants, but it aims to help improve treatment options for Helicobacter pylori infections in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-65 years old;
• • 2. Patients who have had a positive 13C or 14C breath test and have not received Helicobacter pylori eradication therapy before, or who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
• • 3. Voluntarily join this trial and sign the informed consent form.
• Exclusion Criteria:
• • 1. Allergy to the study drug (penicillin, amoxicillin, furazolidone, Tegoprazan, etc.);
• • 2. Patients with active peptic ulcer disease;
• • 3. Patients who have received Helicobacter pylori eradication therapy within half a year;
• • 4. Use of antibiotics, bismuth, histamine H2 receptor antagonists or PPIs for 4 weeks before starting study treatment;
• • 5. use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants;
• • 6. History of esophageal or gastric surgery;
• • 7. Pregnant or lactating women;
• • 8. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
• • 9. Alcoholism.
• • 10. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.