Personalized Treatment for Refractory H Pylori Infection
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|ClinicalTrials.gov Identifier: NCT02547025|
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : September 29, 2017
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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
(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.
- 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.
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
|Contact: Ping-I Hsu, Bachelor||+886-7-342-2121 ext firstname.lastname@example.org|
|Contact: Feng-woei Tsay, Bachelor||+886-7-342-2121 ext email@example.com|
|Kaohsiung Veterans General Hospital||Recruiting|
|Kaohsiung, Taiwan, 813|
|Contact: Ping I Hsu, MD 886-7346-8237 firstname.lastname@example.org|
|Contact: Feng-Woei Chiae, Bachelor +886-7-342-2121 ext 2074 email@example.com|
|Sub-Investigator: Ping I Hsu, MD|
|Study Chair:||Ping-I Hsu, Bachelor||Kaohsiung Veterans General Hospital.|