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
  Purpose

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.


Condition Intervention Phase
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Drug: 10RAC+acetylcystein
Drug: 10RAC+metronidazole
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
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)
Arms Assigned Interventions
Experimental: Acetylcystein
10-day triple therapy plus N-acetyl-cystein to remove the biofilm.
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
Active Comparator: Metronidazole
10-day triple therapy plus metronidazole (concomitant therapy) as active comparator
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572597

Contacts
Contact: Ming-Cheh CHEN, M.D. +886-910-521003 MingCheh_chen@tzuchi.com.tw

Locations
Taiwan
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         
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Ming-Cheh CHEN, MD Buddhist Tzu Chi General Hospital
  More Information

Publications:
Responsible Party: Ming-Cheh Chen, Principal Investigator, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01572597     History of Changes
Other Study ID Numbers: IRB100-26
Study First Received: April 4, 2012
Last Updated: April 5, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Buddhist Tzu Chi General Hospital:
Helicobacter pylori
antibiotic resistance
N-acetylcystein
biofilm
second-line eradication treatment

Additional relevant MeSH terms:
Bacterial Infections
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014