Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02935010

rjkls2016110

Details and patient eligibility

About

With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Enrollment: 382 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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382 participants in 2 patient groups

Tailored therapy

Experimental group

Description:

After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.

Treatment:

Drug: Amoxicillin

Drug: Levofloxacin

Drug: Bismuth Potassium Citrate

Drug: Clarithromycin

Drug: Metronidazole

Drug: Esomeprazole

Empiric therapy

Active Comparator group

Description:

give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days

Treatment:

Drug: Amoxicillin

Drug: Bismuth Potassium Citrate

Drug: Metronidazole

Drug: Esomeprazole