ClinicalTrials.gov
ClinicalTrials.gov Menu

Personalized Treatment for Refractory H Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02547025
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Brief Summary:
In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: rabeprazole+3 antibiotics Drug: rabeprazole+bismuth+2 antibiotics Drug: rabeprazole+amox+tetr+levo Not Applicable

Detailed Description:
They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Treatment for Refractory H Pylori Infection
Study Start Date : December 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: rabeprazole+3 antibiotics
patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days
Drug: rabeprazole+3 antibiotics
(rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.
Other Names:
  • rabeprazole 20 mg
  • amoxicillin 1g
  • clarithromycin 500mg
  • metrondazole 250mg
  • tetracycline 500mg
  • levofloxacin 500mg

Experimental: rabeprazole+bismuth+2 antibiotics
patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days
Drug: rabeprazole+bismuth+2 antibiotics
(rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.
Other Names:
  • rabeprazole 20 mg
  • bismuth subcitrate 120 mg
  • amoxicillin 1g
  • clarithromycin 500mg
  • metrondazole 250mg
  • tetracycline 500mg
  • levofloxacin 500mg

Active Comparator: rabeprazole+amox+tetr+levo
patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days
Drug: rabeprazole+amox+tetr+levo
(rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.
Other Names:
  • rabeprazole 20 mg
  • bismuth subcitrate 120 mg
  • tetracycline 500mg
  • levofloxacin 500mg




Primary Outcome Measures :
  1. Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: eight weeks after the end of anti-H pylori therapy ]
    To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.

  • positive results of both rapid urease test and histology,
  • a positive result of Urea breath test,
  • or a positive result of culture

Exclusion Criteria:

  • ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks,
  • patients with allergic history to the medications used,
  • patients with previous gastric surgery,
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
  • pregnant women.

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): NCT02547025


Contacts
Contact: Ping-I Hsu, Bachelor +886-7-342-2121 ext 8078 williamhsup@yahoo.com.tw
Contact: Feng-woei Tsay, Bachelor +886-7-342-2121 ext 8233 fwchaie@vghks.gov.tw

Locations
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Ping I Hsu, MD    886-7346-8237    williamhsup@yahoo.com.tw   
Contact: Feng-Woei Chiae, Bachelor    +886-7-342-2121 ext 2074    fwchiae@vghks.gov.tw   
Sub-Investigator: Ping I Hsu, MD         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Study Chair: Ping-I Hsu, Bachelor Kaohsiung Veterans General Hospital.

Publications:

Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02547025     History of Changes
Other Study ID Numbers: VGHKS13-CT12-17
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
Helicobacter pylori
third-line therapy
antibiotic susceptibility
Eradication

Additional relevant MeSH terms:
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Amoxicillin
Clarithromycin
Levofloxacin
Ofloxacin
Tetracycline
Antibiotics, Antitubercular
Bismuth tripotassium dicitrate
Rabeprazole
Bismuth
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents