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

Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Clinical Trial

Official title:

Increased Second-line Eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Conventional Triple Therapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01572597
• Other study ID #: IRB100-26
• Status: Recruiting
• Phase: Phase 4
• First received: April 4, 2012
• Last updated: April 5, 2012
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Buddhist Tzu Chi General Hospital
• Contact: Ming-Cheh CHEN, M.D.
• Phone: +886-910-521003
• Email: MingCheh_chen[@]tzuchi.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
• Bacterial Infections

Intervention

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
• 10RAC+metronidazole
10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + metronidazole 500mg b.i.d

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi General Hospital	Hualien

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-eradication rate	A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment.	4 weeks after complete use of drug for treatment	No
Secondary	Influence of Participant's CYP2C19 genotype on re-eradication rate	Influence of Participant's CYP2C19 genotype (EM, IM or PM) on re-eradication rate of Helicobacter pylori	4 weeks after complete use of drug for treatment	No