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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)

Study Interventions

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

Study Arms

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

Study Status

Unknown status

Start Date: June 2011

Completed Date: December 2012

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01572597

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.

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