An interventional study of triple therapy plus bismuth therapy and reverse hybrid therapy in Helicobacter Pylori Infection, sponsored by Kaohsiung Veterans General Hospital.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by Kaohsiung Veterans General Hospital. · Not applicable, Interventional, and Treatment
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Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus bismuth) remains unanswered
With the rising prevalence of antimicrobial resistance, the failure rate of the 7-day standard triple therapy has declined to unacceptable level (\<80%) worldwide. Several regimens were suggested to replace standard triple therapy in the area with high clarithromycin resistance, including sequential therapy, concomitant therapy, hybrid therapy and bismuth containing quadruple therapy. A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving eradication rates of 95%. A clinical trial by Hsu et al from our hospital showed 12-day reverse hybrid therapy also achieved high eradication rate, and improved the compliance of patients. Even prolong the treatment duration of standard triple therapy from 7 days to 12 days, the efficacy of eradication was still \< 90% (85-88%). The limitation of triple therapy in against resistant-stains was still existed. The addition of bismuth (triple therapy plus bismuth) can improve cure rates despite a high prevalence of antimicrobial resistance. The major bismuth effect is to add an additional 30%-40% to the success with resistant infections. However the direct compare the efficacy between 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is still insufficiency in Taiwan and worldwide. Choosing a navel therapy or a modifying triple therapy can get better efficacy, it is remained to be determined. Besides genotyping polymorphism of CYP2C19 influenced the metabolism of proton pump inhibit, and could cause decreasing of eradication rate of standard triple therapy. But the influence in 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is unclear.
Kaohsiung Veterans General Hospital. is the lead sponsor of 107 studies on the registry; 13 are open to participants now.
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pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.
Drug: triple therapy plus bismuth therapy
(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)
Drug: reverse hybrid therapy
Drug page: Clarithromycin
pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.
Also known as: pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500mg, bismuth subcitrate 240mg
(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)
Also known as: pantoprazole 40mg, amoxicillin 1g, clarithromycin 500mg, metronidazole 500mg
Number of Participants in Which H. Pylori Was Eradicated
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.
Time frame: sixth week after the end of anti- H. pylori therapy
Started Jan 2017 (actual). Primary completion is estimated for Dec 2020, 47 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clarithromycin
Kaohsiung Veterans General Hospital. →