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The Efficacy of the 7 Days Tailored Therapy as 2nd Rescue Therapy for Eradication of H. Pylori Infection

NCT02359331 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2023-04-13

No results posted yet for this study

Summary

As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidentally.

In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14 days bismuth contained quadruple 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.

Conditions

  • Helicobacter Infection

Interventions

PROCEDURE

H. pylori culture and antimicrobial susceptibility testing

This intervention will be performed in 7 days tailored therapy group. All the patients who enrolled in this arm, they will be received endoscopy guided biopsy procedure. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin, clarithromycin, metronidazo, tetracycline and moxifloxacin for the H. pylori isolates were examined by use of the serial two fold agar dilution method

DRUG

14 days empirical bismuth quadruple therapy (Proton pump inhibitor)

Giving the 14 days PBMT regimen as 2nd rescue therapy Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.

DRUG

Metronidazole

DRUG

Tetracycline

DRUG

tripotassium dicitrate bismuthate

DRUG

7 days tailored therapy Proton Pump Inhibitor

DRUG

Moxifloxacin

DRUG

Amoxicillin

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Nayoung Kim, M.D., Ph. D · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • South Korea

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 NCT02359331 on ClinicalTrials.gov