Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
NCT Number: NCT02359435
Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection with less cost than standard triple therapy. Whether reverse hybrid therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in first-line treatment.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Kaohsiung City, 813, Taiwan
For this multicentre, single-blind, and randomized-controlled trial (REHYTRI study), the investigator recruited patients with H pylori infection. Using a computer-generated randomization sequence, the investigator randomly allocated patients to either 12-day reverse hybrid therapy (pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg, amoxicillin 1 g for another 5 days; with all drugs given twice daily) or a 12-day standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg, amoxicillin 1 g for 12 days; with all drugs given twice daily) at a 1:1 ratio. Our primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days
Other names: Pantoprazole, Amoxicillin, Clarithromycin, Metronidazole
pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
Other names: Pantoprazole, Amoxicillin, Clarithromycin
Time frame: at the 6th week after the end of anti- H. pylori therapy
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Kaohsiung Veterans General Hospital.
Other
Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection - a Randomized Controlled Trial (REHYTRI Study)
Acronym: REHYTRI
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