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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Clarithromycin; Drug: Esomeprazole; Drug: Metronidazole; Drug: Bismuth Potassium Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02732249

rjkls2016068

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups

Triple regimen group

Active Comparator group

Description:

Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days

Treatment:

Drug: Clarithromycin

Drug: Metronidazole

Drug: Esomeprazole

Low metronidazole group

Experimental group

Description:

Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days

Treatment:

Drug: Clarithromycin

Drug: Metronidazole

Drug: Esomeprazole

Drug: Bismuth Potassium Citrate

High metronidazole group

Experimental group

Description:

Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days

Treatment:

Drug: Clarithromycin

Drug: Metronidazole

Drug: Esomeprazole

Drug: Bismuth Potassium Citrate