Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy
Compare efficacy and safety of 10-day triple therapy (rabeprazole, clarithromycin and amoxicillin) plus N-acetylcystein versus 10-day concomitant therapy (rabeprazole, clarithromycin, amoxicillin and metronidazole) for re-eradication for gastric Helicobacter pylori infection.
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Increased Second-line Eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Conventional Triple Therapy.|
- Re-eradication rate [ Time Frame: 4 weeks after complete use of drug for treatment ] [ Designated as safety issue: No ]A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment.
- Influence of Participant's CYP2C19 genotype on re-eradication rate [ Time Frame: 4 weeks after complete use of drug for treatment ] [ Designated as safety issue: No ]Influence of Participant's CYP2C19 genotype (EM, IM or PM) on re-eradication rate of Helicobacter pylori
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
10-day triple therapy plus N-acetyl-cystein to remove the biofilm.
10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + N-acetyl-cystein 600mg b.i.d
Active Comparator: Metronidazole
10-day triple therapy plus metronidazole (concomitant therapy) as active comparator
10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + metronidazole 500mg b.i.d
Background: Antimicrobial resistance has decreased the eradication rates of common used triple therapy for Helicobacter pylori infection (less than 80%). Such treatment for patient previously with treatment failure, the retreatment eradication rate is less then 50%. Some studies showed the Helicobacter pylori form biofilm to prevent entry of antibiotics, and the N-acetylcystein is helpful to dissolve the biofilm.
Objective: To determine the eradication rate of the common used triple therapy after adding N-acetylcystein for second line treatment for adults infected with Helicobacter pylori in Eastern Taiwan.
Design: Randomized, open-label, prospective controlled trial.
Patients: who are previously failed the primary treatment for eradication and still infected by Helicobacter pylori.
Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.
Intervention: patients with Helicobacter pylori eradication treatment failure are recruited and randomly assigned to receive one of the following therapeutic schemes: 1) study group: rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + N-acetylcystein 0.6g bid for 10 days; 2) control group: rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for 10 days. Repeat upper endoscopy for histologic evaluation, rapid urease test or 13C-urea breath test after 4 week of treatment to assess the treatment result. The influence on the hybrid therapies of antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host were determined.
Expected results: The new second line treatment for eradication of Helicobacter pylori is effective, and to determine the relation of antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host to the treatment result.
|Contact: Ming-Cheh CHEN, M.D.||+886-910-521003||MingCheh_chen@tzuchi.com.tw|
|Buddhist Tzu Chi General Hospital||Recruiting|
|Hualien, Taiwan, 97002|
|Contact: Ming-Cheh CHEN, MD +886-910-521003 MingCheh_chen@tzuchi.com.tw|
|Principal Investigator: Chi-Tan HU, PhD, MD|
|Sub-Investigator: Wei-Yi RAY, MD|
|Principal Investigator:||Ming-Cheh CHEN, MD||Buddhist Tzu Chi General Hospital|