Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Buddhist Tzu Chi General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01572597
First received: April 4, 2012
Last updated: April 5, 2012
Last verified: April 2012

April 4, 2012
April 5, 2012
June 2011
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01572597 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy
Increased Second-line Eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Conventional 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
  • Drug: 10RAC+acetylcystein
    10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + N-acetyl-cystein 600mg b.i.d
    Other Names:
    • Pariet
    • Klaricid
    • Hiconcil
    • Fluimucil
  • Drug: 10RAC+metronidazole
    10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + metronidazole 500mg b.i.d
    Other Names:
    • Pariet
    • Klaricid
    • Hiconcil
    • Flagyl
  • Experimental: Acetylcystein
    10-day triple therapy plus N-acetyl-cystein to remove the biofilm.
    Intervention: Drug: 10RAC+acetylcystein
  • Active Comparator: Metronidazole
    10-day triple therapy plus metronidazole (concomitant therapy) as active comparator
    Intervention: Drug: 10RAC+metronidazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient after treatment for Helicobacter pylori eradication.
  • Still clinically with evidence of gastric Helicobacter pylori infection.

Exclusion Criteria:

  • woman in breast feeding or pregnancy.
  • allergy to drugs used in study.
  • never treated for H. pylori.
  • intolerance to fructose, lactose.
  • patients with hematologic, brain or spinal disorders.
  • patients under 20 years old.
  • patients with malignancy or with decompensated function of vital organs.
Both
20 Years to 80 Years
No
Contact: Ming-Cheh CHEN, M.D. +886-910-521003 MingCheh_chen@tzuchi.com.tw
Taiwan
 
NCT01572597
IRB100-26
Yes
Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
Buddhist Tzu Chi General Hospital
Not Provided
Principal Investigator: Ming-Cheh CHEN, MD Buddhist Tzu Chi General Hospital
Buddhist Tzu Chi General Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP