Tailored Juice-guided Eradication Therapy

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: susceptibility-guided therapy; Drug: empirical clarithromycin-based triple therapy

• Registration Number: NCT04061447
• Lead Sponsor: Kaohsiung Medical University

Brief 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.

Detailed Description

The eradication of H. pylori is an important clinical issue due to its association with many gastrointestinal diseases such as peptic ulcer and even gastric cancer. However, with the global trend of increasing antibiotic resistance, the eradication rate of clarithromycin-based standard triple therapy has declined to less than 80%. To overcome such alarming antibiotic resistance, antimicrobial susceptibility-guided therapy is recommended. However, the literature on gastric juice PCR as susceptibility-guided therapy is scant; therefore, the investigators conducted this prospective randomized controlled trial with the aim of investigating the efficacy of antibiotic susceptibility-guided therapy via gastric juice PCR for first-line eradication.

Study Timeline

• Status Verified: 2016-02
• Study Start: 2016-02-05
• Primary Completion: 2019-05-31
• Study Completion: 2019-07-31
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-16
• Last Update Submitted: 2019-08-18
• Study First Posted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

1. male or non-pregnant female aged more than 20 yeasrs
2. H.pylori infection
3. Mental and legal ability to give a written infomed consent

Exclusion Criteria

1. pregnant women
2. previous allergic reaction to antibiotics (clarithromycin, amoxicillin, levofloxacin, metronidazole and Proton-pump inhibitor(rabeprazole)
3. patients with previous gastric surgery
4. the coexistence of serious concomitant illness(for example, decompensated liver cirrhosis, uremia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
susceptibility-guided therapy	susceptibility-guided therapy	In the group of the empirical triple therapy, patients received rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.
empirical clarithromycin-based triple therapy	empirical clarithromycin-based triple therapy	In the group of gastric juice susceptibility-guided 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.

Primary Outcome Measures

Name	Time	Method
The rate of H.pylori eradication	6 weeks	Four-to-six weeks after treatment, all patients received the 13C-urea breath test to confirm H. pylori infection status.

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan