Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

• Status: Completed
• Trial end date: 2017-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Amoxicillin; Bismuth; Citric Acid; Clarithromycin; Esomeprazole; Metronidazole; Potassium Citrate

Criteria

Inclusion Criteria:

• Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease

• Ability and willingness to participate in the study and to sign and give informed consent

• confirmed H. pylori infection

Exclusion Criteria:

• Previous H. pylori eradication therapy

• Less than 18 years old

• With history of H. pylori infection treatment

• With previous gastric surgery

• 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