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NCT03431688 Clinical Trial

Tailored Therapy for Clarithromycin-Resistant H. Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:
Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03431688
Other study ID # KangdongSHH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date December 30, 2020

Study information
Verified date March 2019
Source Kangdong Sacred Heart Hospital
Contact Woon Geon Shin
Phone 82-2-2225-2814
Email sgun9139@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.

Recruitment information / eligibility
Status Recruiting
Enrollment 660
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 85 Years
Eligibility Inclusion Criteria:

- peptic ulcer disease

- H. pylori gastritis

- low grade MALT lymphoma

Exclusion Criteria:

- history of gastric cancer surgery

- severe comorbidity (ESRD, LC)

- hypersensitivity to drug

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PAM
treatment with PPI, metonidazole, amoxicillin
• PBMT
treatment with PPI, metonidazole, bismuth, tetracyclin

Locations
Country Name City State
Korea, Republic of Kangdong Sacred Heart Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kangdong Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary H. pylori eradication rate H. pylori eradication rate 14 days
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