Helicobacter Pylori Eradication According to DPO-PCR Methods: Duration of Triple Therapy and Bismuth Quadruple According to Clarithromycin Resistance Patterns (K-CREATE Study)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance have shown that regional resistance patterns to antibiotics such as clarithromycin are increasing. Recent studies show that examining genotype resistance is effective in eradication. Currently, dual priming oligonucleotide-polymerase chain reaction (DPO-PCR) is used to measure clarithromycin resistance. No study has compared the duration of eradication regimens according to DPO-PCR results. This study compares the eradication rate of 7-day triple therapy with 14-day triple therapy in clarithromycin susceptible strains from DPO-PCR. The investigators also aimed to compare the eradication rates of 7-day bismuth quadruple therapy with 14-day bismuth quadruple therapy from clarithromycin-resistant strains from DPO-PCR.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: t
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• Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination.

⁃ Participants who voluntarily want to participate in this study.

Locations
Other Locations
Republic of Korea
Incheon St. Mary's Hospital
RECRUITING
Incheon
Contact Information
Primary
Joon S Kim, MD, PhD
kijoons@nate.com
82322805057
Time Frame
Start Date: 2021-07-14
Estimated Completion Date: 2025-03-30
Participants
Target number of participants: 1230
Treatments
Experimental: 7-day triple therapy and 7-day bismuth quadruple therapy
7-day triple therapy is consisted of proton pump inhibitor (PPI), amoxicillin and clarithromycin for seven days 7-day bismuth quadruple therapy is consisted of PPI, bismuth, tetracycline, metronidazole for seven days
Active_comparator: 14-day triple therapy and 14-day bismuth quadruple therapy
14-day triple therapy is consisted of PPI, amoxicillin and clarithromycin for fourteen days 14-day bismuth quadruple therapy is consisted of PPI, bismuth, tetracycline, metronidazole for fourteen days
Related Therapeutic Areas
Sponsors
Leads: Incheon St.Mary's Hospital
Collaborators: Korea Health Industry Development Institute

This content was sourced from clinicaltrials.gov

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