Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection
|ClinicalTrials.gov Identifier: NCT02249546|
Recruitment Status : Unknown
Verified September 2014 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
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
- Whether triple therapy containing N-acetyl cysteine is more effective than standard triple therapy
- the impact of antibiotic resistance and cytochrome P450 C19(CYP2C19) polymorphism on the eradication rate of triple therapy containing N-acetyl cysteine.
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: N-acetylcysteine + PPI-amoxicillin-clarithromycin Drug: PPI-amoxicillin-clarithromycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||654 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Efficacy of Triple Therapy With or Without Acetylcysteine in the First Line of Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||October 2016|
Experimental: Acetylcysteine + PPI-amoxicillin-clarithromycin
N-acetylcysteine 600mg bid Dexlansoprazole 60mg qd Amoxicillin 1000mg bid Clarithromycin 500mg bid All for 14 days
Drug: N-acetylcysteine + PPI-amoxicillin-clarithromycin
Active Comparator: PPI-amoxicillin-clarithromycin
Dexlansoprazole 60mg qd Amoxicillin 1000mg bid Clarithromycin 500mg bid All for 14 days
- Helicobacter pylori eradication rate [ Time Frame: 6wks ]
- Compliance [ Time Frame: 14 days ]
- Adverse effects [ Time Frame: 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249546
|Contact: Chieh-Chang Chen, MD, MScemail@example.com|
|Department of Internal Medicine, National Taiwan Univeristy Hospital Yun-Lin branch||Not yet recruiting|
|Douliou City, Yunlin County, Taiwan, 640|
|National Taiwan Univeristy Hospital||Recruiting|
|Contact: Chieh-Chang Chen, MD|
|Sub-Investigator: Jyh-Ming Liou, MD, PHD|
|Sub-Investigator: Chieh-Chang Chen, MD|
|Principal Investigator: Ming-Shiang Wu, MD, PHD|
|Principal Investigator:||Ming-Shiang Wu, MD, PHD||National Taiwan University Hospital|