Actively Recruiting
Helicobacter Pylori Eradication According to DPO-PCR Methods (K-CREATE) Study)
Led by Incheon St.Mary's Hospital · Updated on 2024-05-16
1230
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
I
Incheon St.Mary's Hospital
Lead Sponsor
K
Korea Health Industry Development Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Helicobacter Pylori Eradication According to DPO-PCR Methods (K-CREATE) Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 to 75 years
- Diagnosed with Helicobacter pylori infection within 3 months by rapid urease test, urea breath test, or histopathologic examination
- Willing to voluntarily participate in the study
You will not qualify if you...
- Previous Helicobacter pylori eradication treatment
- History of stomach surgery
- Allergy or adverse reactions to eradication medications
- Use of proton-pump inhibitors within 2 weeks or histamine 2 receptor blockers within 1 week
- Use or need for continuous use of aspirin (except low-dose for heart disease prevention), intravenous or oral NSAIDs, anticholinergics, prostaglandin analogs, pro-motility drugs, or sucralfate within 1 week
- Use of antibiotics within 4 weeks
- Pregnant, breastfeeding, or unwilling to avoid pregnancy during the study
- Use of specified medications including certain statins, antivirals, and others listed
- Presence of infectious mononucleosis, central nervous system infection, hematologic disease, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or torsades de pointes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Incheon St. Mary's Hospital
Incheon, South Korea
Actively Recruiting
Research Team
J
Joon S Kim, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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