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

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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: N-acetylcysteine + PPI-amoxicillin-clarithromycin Drug: PPI-amoxicillin-clarithromycin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 654 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: PPI-amoxicillin-clarithromycin
Triple therapy




Primary Outcome Measures :
  1. Helicobacter pylori eradication rate [ Time Frame: 6wks ]

Secondary Outcome Measures :
  1. Compliance [ Time Frame: 14 days ]
  2. Adverse effects [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • H. pylori infected patients who have willingness to receive eradication therapy

Exclusion Criteria:

  • (1) history of gastrectomy, (2)gastric malignancy, including adenocarcinoma and lymphoma, (3) previous allergic reaction to antibiotics (amoxicillin, clarithromycin), N-acetyl cysteine and prompt pump inhibitors (dexlansoprazole), (4)contraindication to treatment drugs, (5) pregnant or lactating women, (6) severe concurrent disease. (7) phenylketonuria (8) Patients who cannot give informed consent by himself or herself.

Information from the National Library of Medicine

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


Contacts
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Contact: Chieh-Chang Chen, MD, MSc 886972652550 chiehchang.chen@gmail.com

Locations
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Taiwan
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
Taipei, Taiwan
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         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ming-Shiang Wu, MD, PHD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital, Professor
ClinicalTrials.gov Identifier: NCT02249546     History of Changes
Other Study ID Numbers: 201406074MINC
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Acetylcysteine
N-monoacetylcystine
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antiviral Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Antidotes