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

NCT01572597 | Unknown Phase 4 DMC

• 1 other identifier: IRB100-26
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Keywords

Helicobacter pylori; antibiotic resistance; N-acetylcystein; biofilm; second-line eradication treatment

Outcome Measures

Primary Outcomes (1)

• Re-eradication rate

  A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment.

  4 weeks after complete use of drug for treatment

Secondary Outcomes (1)

• Influence of Participant's CYP2C19 genotype on re-eradication rate

  4 weeks after complete use of drug for treatment

Study Arms (2)

Acetylcystein

EXPERIMENTAL

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

Drug: 10RAC+acetylcystein

Metronidazole

ACTIVE COMPARATOR

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

Drug: 10RAC+metronidazole

Interventions

10RAC+acetylcystein DRUG

10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + N-acetyl-cystein 600mg b.i.d

Also known as: Pariet, Klaricid, Hiconcil, Fluimucil

Acetylcystein

10RAC+metronidazole DRUG

10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + metronidazole 500mg b.i.d

Also known as: Pariet, Klaricid, Hiconcil, Flagyl

Metronidazole

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient after treatment for Helicobacter pylori eradication.
• Still clinically with evidence of gastric Helicobacter pylori infection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan, 97002, Taiwan

RECRUITING

Related Publications (2)

• 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.

  PMID: 19804842 BACKGROUND

• 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.

  PMID: 20478402 BACKGROUND

MeSH Terms

Interventions

Rabeprazole; Clarithromycin; Acetylcysteine; Metronidazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Cysteine; Amino Acids, Sulfur; Amino Acids; Amino Acids, Peptides, and Proteins; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Ming-Cheh CHEN, MD

  Buddhist Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Cheh CHEN, M.D.

CONTACT

+886-910-521003; MingCheh_chen@tzuchi.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

TW (1)