Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection
Comparison of the Efficacy of Triple Therapy With or Without Acetylcysteine in the First Line of Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial
1 other identifier
interventional
654
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2014
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedSeptember 25, 2014
September 1, 2014
1.9 years
September 18, 2014
September 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Helicobacter pylori eradication rate
6wks
Secondary Outcomes (2)
Compliance
14 days
Adverse effects
14 days
Study Arms (2)
Acetylcysteine + PPI-amoxicillin-clarithromycin
EXPERIMENTALN-acetylcysteine 600mg bid Dexlansoprazole 60mg qd Amoxicillin 1000mg bid Clarithromycin 500mg bid All for 14 days
PPI-amoxicillin-clarithromycin
ACTIVE COMPARATORDexlansoprazole 60mg qd Amoxicillin 1000mg bid Clarithromycin 500mg bid All for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- H. pylori infected patients who have willingness to receive eradication therapy
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Taiwan Univeristy Hospital
Taipei, Taiwan, Taiwan
Department of Internal Medicine, National Taiwan Univeristy Hospital Yun-Lin branch
Douliu, Yunlin County, 640, Taiwan
Related Publications (1)
Chen CC, Luo JC, Fang YJ, Lee JY, Kuo CC, Yang TH, Chiu MC, Yu JJ, Bair MJ, Chen PY, Chou CK, Chen CY, Chang CY, Hsu YC, Tseng CH, Hsu WF, Hu WH, Tsai MH, Hsieh CL, Chen MJ, Shun CT, Liu TY, Lee YC, Liou JM, Wu MS; and for the Taiwan Gastrointestinal Disease and Helicobacter Consortium. Comparison of the effect of clarithromycin triple therapy with or without N-acetylcysteine in the eradication of Helicobacter pylori: a randomized controlled trial. Therap Adv Gastroenterol. 2020 Jul 31;13:1756284820927306. doi: 10.1177/1756284820927306. eCollection 2020.
PMID: 32821287DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-Shiang Wu, MD, PHD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 18, 2014
First Posted
September 25, 2014
Study Start
September 1, 2014
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
September 25, 2014
Record last verified: 2014-09