Triple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori Infection

Last updated: June 9, 2017
Sponsor: National Taiwan University Hospital
Overall Status: Trial Status Unknown

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01906879
201304017MINB
  • Ages > 20
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown.

Therefore, we aim to compare the eradication rates and long term re-infection rates of quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple therapy for 14 days.

Methods: This will be a multi-center, open labeled, randomized control trial Patients: H. pylori infected patients who have willingness to receive eradication therapy

Testing for H. pylori infection Before First Line Ttreatment

(1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT will be considered as H. pylori infected

After First Line Treatment: C13-Urea breath test will be used to assess the existence of H. pylori 6-8 weeks after first line therapy.

Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H. pylori 1 year after eradication therapy

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients aged greater than 20 years who have H. pylori infection without prior eradicationtherapy and are willing to receive the sequential therapy will be eligible for enrolment.Written informed consents will be obtained from all patients prior to enrollment.

Exclusion

Exclusion Criteria: Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastricmalignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction toantibiotics (amoxicillin, clarithromycin, metronidazole, or levofloxacin) and prompt pumpinhibitors (lansoprazole), (5)contraindication to treatment drugs, (6) pregnant orlactating women, (7) severe concurrent diseases, and (8) Patients who cannot give informedconsent by himself or herself.

Study Design

Total Participants: 1620
Study Start date:
June 01, 2013
Estimated Completion Date:
December 31, 2017

Study Description

First line therapy: open labeled, randomized control trial, randomized into one of the three groups Group (A): triple therapy for 14 days D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid Group (B): non-bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid Group (C): bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid

Second line therapy: patients who fail from first line treatment will be rescue with the following treatment Group (A) Patient who fail from triple therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (B) Patient who fail from non-bismuth quadruple therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (C) Patients who fail from bismuth quadruple therapy will be retreated with non-bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid

Connect with a study center

  • Chiayi Christian Hospital

    Chiayi,
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital, Hsinchu Branch

    Hsinchu,
    Taiwan

    Active - Recruiting

  • E- DA Hospital and I-Shou University

    Kaohsiung,
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung,
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital, Taipei

    Taipei,
    Taiwan

    Active - Recruiting

  • Ming-Shiang Wu

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital, Taitung

    Taitung,
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital, Yun-Lin Branch

    Yun-Lin County,
    Taiwan

    Active - Recruiting

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