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

Buddhist Tzu Chi General Hospital

Status and phase: Unknown; Phase 4

Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Treatments: Drug: 10RAC+acetylcystein; Drug: 10RAC+metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01572597

IRB100-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Acetylcystein

Experimental group

Description:

10-day triple therapy plus N-acetyl-cystein to remove the biofilm.

Treatment:

Drug: 10RAC+acetylcystein

Metronidazole

Active Comparator group

Description:

10-day triple therapy plus metronidazole (concomitant therapy) as active comparator

Treatment:

Drug: 10RAC+metronidazole