Tailored Juice-guided Eradication Therapy

Helicobacter Pylori Infection Clinical Trial

— HP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061447
• Other study ID #: KMUHIRB-G(I)-20150043
• Status: Completed
• Phase: N/A
• Start date: February 5, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2016
• Source: Kaohsiung Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• susceptibility-guided therapy
rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of H.pylori eradication	Four-to-six weeks after treatment, all patients received the 13C-urea breath test to confirm H. pylori infection status.	6 weeks