Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Conditions
Keywords
Helicobacter pylori, antibiotic resistance, N-acetylcystein, biofilm, second-line eradication 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.
Interventions
DRUG10RAC+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
DRUG10RAC+metronidazole
10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + metronidazole 500mg b.i.d
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-eradication rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Influence of Participant's CYP2C19 genotype on re-eradication rate | 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 |
Countries
Taiwan
Contacts
Primary ContactMing-Cheh CHEN, M.D.
Outcome results
None listed