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Eradication Rates of Helicobacter Pylori and Its Affecting Factors

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ClinicalTrials.gov Identifier: NCT01922505
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

Brief Summary:
The purpose of this study is to investigate the trend of eradication rates of first-line triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect the eradication in Korean.

Condition or disease Intervention/treatment
Helicobacter Infections Drug: PPI triple therapy

Detailed Description:
A PPI triple regimen combining a proton pump inhibitor(PPI) with two antibiotics (amoxicillin and clarithromycin) is currently considered the gold standard therapy for eradication of H. pylori. However, recently the eradication rate with first-line treatment has a tendency to decrease because of increasing antibiotics resistance. In addition, PPI is mainly metabolized by cytochrome p450 2C19 (CYP2C19) in the liver and several reports have suggested that differences in th CYP2C19 genotype are associated with H. pylori eradication failure. Thus, the first aim of this study is to investigate the trend of eradication rates of first-line triple therapy in recent ten years. And the second aim is to analyze the antibiotics resistance rate for H. pylori by using culture minimal inhibitory concentrations(MICs) result and to analyze the association between CYP2C19 genotype and eradication rate of H.pylori. And also investigate the other clinical factors (age, gender, underlying disease, cigarette smoking and alcohol use) that affect the eradication rate.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: The Trend of Eradication Rates of First-line Triple Therapy for Helicobacter Pylori and Clinical Factors That Affect the Eradication in Korean: Single Center Experience for Recent Ten Years
Study Start Date : January 2003
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Group/Cohort Intervention/treatment
PPI triple therapy
7-day PPI triple therapy regimen: PPI (esomeprazole 40 mg or omeprazole 20 mg or lansoprazole 30 mg or pantoprazole 40 mg or rabeprazole 20 mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.
Drug: PPI triple therapy



Primary Outcome Measures :
  1. Eradication Rates of First-line Triple Therapy for Helicobacter pylori [ Time Frame: Four weeks after completing eradication therapy ]
    Non invasive H. pylori test (13C-urea breath test(UBT)) or invasive H. pylori test (Giemsa histology, Rapid Urease test) were performed after four weeks after completing eradication therapy.


Secondary Outcome Measures :
  1. Clinical Factors that Affect the Eradication [ Time Frame: Four weeks after completing eradication therapy ]

    Main variables are Cytochrome P450 2C19 (CYP2C19) genotype and Antibiotics resistance by H. pylori culture MICs result.

    Other variables are age, gender, underlying disease (hypertension, diabetes, chronic liver, lung, kidney diseases), cigarette smoking and alcohol use.




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Ages Eligible for Study:   16 Years to 92 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
H. pylori positive patient
Criteria

Inclusion Criteria:

  • Patients who proven H. pylori infection by invasive or non-invasive H. pylori test
  • Patients treated with First-line triple therapy (PPI + Amoxicillin + Clarithromycin)

Exclusion Criteria:

  • Previous eradication therapy for H. pylori
  • Follow-up loss patients after eradication therapy
  • Other treatment regimen
  • Poor medication compliance (<80%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922505


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Bundang-gu, Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital

Additional Information:

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Responsible Party: Nayoung Kim, Professor, M.D., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01922505     History of Changes
Other Study ID Numbers: B-1308-214-108
2012R1A1A3A04002680 ( Other Identifier: National Research Foundation of Korea )
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections