Tailored Juice-guided Eradication Therapy

NCT04061447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2019-08-20

No results posted yet for this study

Summary

In this study, the investigators aim to investigate the efficacy of tailored anti-microbial susceptibility guided-therapy via gastric juice PCR, compared with empirical standard triple therapy.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

susceptibility-guided therapy

rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.

DRUG

empirical clarithromycin-based triple therapy

The eradication regimen was based on the susceptibility results of gastric PCR. If clarithromycin was sensitive, the regimen contained rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days. If clarithromycin was resistant and levofloxacin was sensitive, the regimen was rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and levofloxacin 500mg QD for seven days. If clarithromycin and levofloxacin were both resistant, the regimen was either reverse-hybrid therapy (rabeprazole 20mg B.I.D x 14 days, amoxicillin 1000mg B.I.D, x 14 days, clarithromycin 500mg B.I.D for 7 days, and metronidazole 500mg B.I.D for 7 days) or high dose dual therapy (rabeprazole 20mg Q.I.D and amoxicillin 1000mg Q.I.D for 14 days). Owing to this open design, either reverse-hybrid therapy or high dose dual therapy was chosen by doctors' preference.

Sponsors & Collaborators

  • Kaohsiung Medical University

    lead OTHER

Principal Investigators

  • Deng-Chyang Wu, MD, PHD · Kaohsiung Medical University

  • Chao-Hung Kuo, MD, PHD · Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-05
Primary Completion
2019-05-31
Completion
2019-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04061447 on ClinicalTrials.gov