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Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection

NCT02249546 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2014-09-25

No results posted yet for this study

Summary

Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. The triple treatment including a proton pump inhibitor, clarithromycin, and amoxicillin or metronidazole to treat H pylori infection, proposed at the first Maastricht conference has become universal since all the consensus conferences and guidelines around the world recommended it. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy.

The H. pylori persistence in human infections and its resistance to the drugs commonly used in antimicrobial therapy have been attributed not only to genetic variability, but also to ability of H. pylori to form biofilm as a strategy to overcome environmental stress and to protect itself. Several recent reports indicate that H. pylori forms biofilm either in vitro or in vivo, N-acetylcysteine (NAC) were thought to reduce and prevent biofilm formation. Two small-scale clinical trials showed NAC offers additive effect on eradication effects of H. pylori therapy. A recent trial showed N-acetylcysteine pre-treatment before a culture-guided antibiotic regimen is effective in treating refractory H. pylori infection.

Aims: Therefore, we aim to assess

1. Whether triple therapy containing N-acetyl cysteine is more effective than standard triple therapy
2. the impact of antibiotic resistance and cytochrome P450 C19(CYP2C19) polymorphism on the eradication rate of triple therapy containing N-acetyl cysteine.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

N-acetylcysteine + PPI-amoxicillin-clarithromycin

DRUG

PPI-amoxicillin-clarithromycin

Triple therapy

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Ming-Shiang Wu, MD, PHD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-08-31
Completion
2016-10-31

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 NCT02249546 on ClinicalTrials.gov