Bacterial Infection Due to Helicobacter Pylori (H. Pylori) | 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) research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:10RAC+acetylcystein10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + N-acetyl-cystein 600mg b.i.d
Drug:10RAC+metronidazole10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + metronidazole 500mg b.i.d
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Acetylcystein10-day triple therapy plus N-acetyl-cystein to remove the biofilm.
Metronidazole10-day triple therapy plus metronidazole (concomitant therapy) as active comparator
Start Date: June 2011
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: Re-eradication rate
Secondary Outcome: Influence of Participant's CYP2C19 genotype on re-eradication rate
Study sponsors, principal investigator, and references
Principal Investigator: Ming-Cheh CHEN, MD
Lead Sponsor: Buddhist Tzu Chi General Hospital
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.