Rescue Therapy for Helicobacter Pylori Infection
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT05874544
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection and with previous treatment experience
- subjects naive to H. pylori treatment,
- under 18 or over 80 years old
- history of gastrectomy
- pregnant or lactating women
- Previous history of tuberculosis
- Allergy to any of the study drugs
- severe systemic diseases or malignancy
- administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tetracycline Bismuth Quadruple Therapy Bismuth Potassium Citrate Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid Dual Therapy Amoxicillin Vonoprazan 20mg bid, amoxicillin 1000mg tid Tetracycline Bismuth Quadruple Therapy Tetracycline Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid Tetracycline Bismuth Quadruple Therapy Vonoprazan Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid Rifabutin Triple Therapy Rifabutin Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid Rifabutin Triple Therapy Amoxicillin Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid Tetracycline Bismuth Quadruple Therapy Metronidazole Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid Rifabutin Triple Therapy Vonoprazan Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid Dual Therapy Vonoprazan Vonoprazan 20mg bid, amoxicillin 1000mg tid
- Primary Outcome Measures
Name Time Method Helicobacter pylori eradication rate Six weeks after completion of therapy 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).
- Secondary Outcome Measures
Name Time Method Compliance rate Within 7 days after completion of therapy Compliance was defined as poor when they had taken less than 80% of the total medication
Rate of adverse effects Within 7 days after completion of therapy 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.
Trial Locations
- Locations (3)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Shanghai Songjiang District Central Hospital
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Zhejiang University school of Medicine
🇨🇳Hangzhou, Zhejiang, China