Culture-based tailored therapy as primary treatment of Helicobacter pylori infection

Efficacy and safety of culture-based tailored therapy as primary treatment of Helicobacter pylori infection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004877

Enrollment

312

Registered

2020-04-03

Start date

2020-04-15

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : H. pylori eradication regimen would be prescribed between the empirical therapy group and the tailored therapy group after randomization (ratio 1:3). 1. The empirical therapy group regimen

Proton pump inhibitor standard dose bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, metronidazole 500 mg bid, 10 days 2. The tailored therapy group regimen according to the antibiotics resistance

i) clarithromycin sensitive: Proton pump inhibitor standard dose bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, 10 days ii) clarithromycin resistant/metronidazole sensitive: Proton pump inhibito

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients with upper GI symptom - patients with suspected peptic ulcer disease or upper GI neoplasm - Those who need an upper GI endoscopy for gastric cancer screening - Those who have confirmed Helicobacter pylori infection through culture test - A person who consented to participate in this study and voluntarily signed a written consent

Exclusion criteria

Exclusion criteria: - patients who have H.pylori eradication history - patients who received esophagectomy, gastrectomy, or duodenectomy - Those who have a history of allergies to test drugs - acute GI bleeding patients - Persons who have taken proton pump inhibitors or histamine receptor antagonists within 4 weeks prior to upper gastrointestinal endoscopy, or who need to take proton pump inhibitors or histamine receptor antagonists within 4 weeks before randomization and until the end of the study participation period after randomization. - Those who took antibiotics or bismuth within 4 weeks prior to upper gastrointestinal endoscopy, or who need to take antibiotics or bismuth within 4 weeks before randomization and until the end of the study period after randomization - Those who need to take oral or intravenous steroids during the study period - Women who are pregnant, lactating, or women of childbearing potential have not undergone infertility surgery or are unwilling to use effective methods of contraception during the trial. - Those who fail to comply with the planned visit schedule or follow the test procedure - A person who has a health risk or is difficult to evaluate the purpose of the trial by the investigator's judgment - Those who fall under the following conditions; Infectious mononucleosis, patients with central nervous system infection, patients with blood disease or history, patients with organic neurological disorders, patients with genetic problems such as galactose intolerance and Lapp lactose deficiency or glucose-galactose uptake, QT prolongation or ventricular arrhythmia ( Patients with a history of Torsades de pointes)

Design outcomes

Primary

Measure	Time frame
Eradication of H. pylori	—

Secondary

Measure	Time frame
compliance and side effect of regimen	—

Countries

Korea, Republic of

Contacts

Public ContactJeong Hoon Lee

Asan Medical Center

Outcome results