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Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

Not Applicable
Completed
Conditions
Helicobacter Pylori Infection
Interventions
Registration Number
NCT04879992
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Brief Summary

Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of 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
COMPLETED
Sex
All
Target Recruitment
413
Inclusion Criteria
  • ability and willingness to participate in the study and to sign and give informed consent
  • Confirmed H. pylori infection and with previous treatment experience
Exclusion Criteria
  • Less than 18 years old
  • With previous gastric surgery
  • Previous history of tuberculosis
  • Major systemic diseases
  • Pregnancy or lactation
  • Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Tetracycline Bismuth Quadruple TherapyBismuth Potassium CitrateEsomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
rifabutin triple therapyamoxicillin rifabutinEsomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid
Tetracycline Bismuth Quadruple TherapyTetracycline,MetronidazoleEsomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
Tetracycline Bismuth Quadruple TherapyEsomeprazoleEsomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
rifabutin triple therapyEsomeprazoleEsomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid
Primary Outcome Measures
NameTimeMethod
Helicobacter pylori eradication rateSix weeks after completion of therapy

Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was

Secondary Outcome Measures
NameTimeMethod
Compliance rateWithin 7 days after completion of therapy

Compliance was defined as poor when they had taken less than 80% of the total medication

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

🇨🇳

Shanghai, Shanghai, China

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