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

• ClinicalTrials.gov Identifier: NCT01572597
• Recruitment Status: Unknown
• First Posted: April 6, 2012
• Last Update Posted: April 6, 2012
• Sponsor: Buddhist Tzu Chi General Hospital
• Information provided by (Responsible Party): Ming-Cheh Chen, Buddhist Tzu Chi General Hospital

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)	Drug: 10RAC+acetylcystein; Drug: 10RAC+metronidazole	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: June 2011
• Estimated Primary Completion Date: December 2012
• Estimated Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Re-eradication rate [ Time Frame: 4 weeks after complete use of drug for treatment ]
   A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment.

Secondary Outcome Measures :

1. Influence of Participant's CYP2C19 genotype on re-eradication rate [ Time Frame: 4 weeks after complete use of drug for treatment ]
   Influence of Participant's CYP2C19 genotype (EM, IM or PM) on re-eradication rate of Helicobacter pylori

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Wu DC, Hsu PI, Wu JY, Opekun AR, Kuo CH, Wu IC, Wang SS, Chen A, Hung WC, Graham DY. Sequential and concomitant therapy with four drugs is equally effective for eradication of H pylori infection. Clin Gastroenterol Hepatol. 2010 Jan;8(1):36-41.e1. doi: 10.1016/j.cgh.2009.09.030. Epub 2009 Oct 3.

Cammarota G, Branca G, Ardito F, Sanguinetti M, Ianiro G, Cianci R, Torelli R, Masala G, Gasbarrini A, Fadda G, Landolfi R, Gasbarrini G. Biofilm demolition and antibiotic treatment to eradicate resistant Helicobacter pylori: a clinical trial. Clin Gastroenterol Hepatol. 2010 Sep;8(9):817-820.e3. doi: 10.1016/j.cgh.2010.05.006. Epub 2010 May 31.

• Responsible Party: Ming-Cheh Chen, Principal Investigator, Buddhist Tzu Chi General Hospital
• ClinicalTrials.gov Identifier: NCT01572597
• Other Study ID Numbers: IRB100-26
• First Posted: April 6, 2012
• Last Update Posted: April 6, 2012
• Last Verified: April 2012

Keywords provided by Ming-Cheh Chen, Buddhist Tzu Chi General Hospital:

Helicobacter pylori; antibiotic resistance; N-acetylcystein; biofilm; second-line eradication treatment

Additional relevant MeSH terms:

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Metronidazole; Clarithromycin; Acetylcysteine; Rabeprazole; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Protein Synthesis Inhibitors; 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