A Phase 3 interventional study of Standard triple therapy and Bismuth quadruple therapy in Helicobacter Pylori Infection and Family History of Stomach Cancer, sponsored by National Cancer Center, Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-08.
Sponsored by National Cancer Center, Korea · Phase 3, Interventional, and Treatment
In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.
Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 352 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.
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Men and women aged 18 or more including following conditions
Exclusion Criteria:
7 day-PPI based standard triple therapy
Drug: Standard triple therapy
10 day-bismuth quadruple therapy
Drug: Bismuth quadruple therapy
Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days
Also known as: 7-day PPI-based standard triple therapy
Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days
Also known as: 10-day Bismuth quadruple therapy
H. pylori eradication rate
Time frame: 8 weeks after H. pylori treatment
Complications of H. pylori treatment
Time frame: 1 month after H. pylori treatment
Compliance to H. pylori treatment
Time frame: 1 month
H. pylori infection status at 1 year after H. pylori treatment
Time frame: 1 year after H. pylori treatment
H. pylori reinfection rate
Time frame: 3 years after success of H. pylori eradication
Factors associated with H. pylori reinfection
Time frame: 3 years after success of H. pylori treatment
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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National Cancer Center, Korea