Clinical trial NCT01572597: Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy
Official title: Increased Second-line Eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Conventional Triple Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Keywords: Helicobacter pylori
antibiotic resistance
N-acetylcystein
biofilm
second-line eradication treatment
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Re-eradication rate
timeFrame: 4 weeks after complete use of drug for treatment
Secondary outcomes:
measure: Influence of Participant's CYP2C19 genotype on re-eradication rate
timeFrame: 4 weeks after complete use of drug for treatment
Other outcomes:
Locations:
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
Study officials:
affiliation: Buddhist Tzu Chi General Hospital
name: Ming-Cheh CHEN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.