A Phase 4 interventional study of Vonoprazan and Bismuth Potassium Citrate in Helicobacter Pylori Infection, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 4 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
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The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg tid, Metronidazole 400mg tid
Drug: Vonoprazan · Drug: Bismuth Potassium Citrate · Drug: Minocycline,Metronidazole
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg qid
Drug: Vonoprazan · Drug: Bismuth Potassium Citrate · Drug: Minocycline,Metronidazole
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg tid
Drug: Vonoprazan · Drug: Bismuth Potassium Citrate · Drug: Minocycline,Metronidazole
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Drug: Vonoprazan · Drug: Bismuth Potassium Citrate · Drug: Tetracycline,Metronidazole
Potassium competitive acid blocker
Gastric mucosal protective drug with anti-H. pylori effect
Drug pages: Tetracycline · Metronidazole
Antibiotics for H. pylori eradication
Drug pages: Minocycline · Metronidazole
Antibiotics for H. pylori eradication
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
Time frame: Six weeks after completion of therapy
Rate of adverse effects
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or severe" (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney.
Time frame: Within 7 days after completion of therapy
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Time frame: Within 7 days after completion of therapy
Ran from Aug 2024 to primary completion in Feb 2026, 18 months.
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Studies of the drugs tested here: Minocycline · Metronidazole
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