Tailored Therapy for Clarithromycin-Resistant H. Pylori

Not Applicable

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: PAM; Drug: PBMT

• Registration Number: NCT03431688
• Lead Sponsor: Kangdong Sacred Heart Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-13
• Study Start: 2018-10-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 660

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAM	PAM	treatment with PPI, metonidazole, amoxicillin
PBMT	PBMT	treatment with PPI, metonidazole, bismuth, tetracyclin

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	14 days	H. pylori eradication rate

Trial Locations

Locations (1)

Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of