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Completed

NCT Number: NCT04061447

Tailored Juice-guided Eradication Therapy

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

susceptibility-guided therapy

Drug

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

empirical clarithromycin-based triple therapy

Drug

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 outcomes

  1. The rate of H.pylori eradication

    Time frame: 6 weeks

    Four-to-six weeks after treatment, all patients received the 13C-urea breath test to confirm H. pylori infection status.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Registry information

Official study title

Tailored Antibiotic Susceptibility-guided Therapy Via Gastric Juice PCR for First-line H Pylori Eradication, a Prospective Randomized Controlled Trial

Acronym: HP

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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