NCT02373280

The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection

A Prospective, Single-center, Open-label, Clinical Trial to Compare the 10-day Sequential Therapy and 7-day Culture Based Tailored Therapy for the Eradication of Helicobacter Pylori

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.

Detailed description

As increasing antimicrobial resistance in Korea, the effectiveness of empirical Helicobacter pylori (H. pylori) therapies have been declined. Recently, 10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication. Thus, in this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days tailored therapy (7 day PPI based triple therapy, bismuth quadruple therapy or moxifloxacin contained triple therapy) for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 day sequential therapy for the first eradication of H. pylori infection, and the investigators analyzed the prevalence of the antibiotic resistance in the tailored therapy group.

Conditions

• Helicobacter Infection

Interventions

Type	Name	Description
DRUG	10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)	In this group, patients will receive the 10 day sequential regimen for eradication of H. pylori. 10 day sequential regimen is like follows; Esomeprazole 40 mg bid 10 days (D1-D10)+amoxicillin 1 g bid 5 days (D1-D5)+clarithromycin 500 mg bid 5 days (D6-D10)+metronidazole 500 mg tid 5 days (D6-D10).
DRUG	7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)	the participants received PPI based triple therapy\[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\]
DRUG	7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]	moxifloxacin triple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)\].
DRUG	7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)	bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+amoxicillin 1 g bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\], bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, 300 mg qid 7 days (D1-D7)+Metronidazole, 500 mg tid 7 days (D1-D7)+Tetracycline 500 mg qid 7 days (D1-D7)\] If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days.

Timeline

• Start date: 2014-08-01
• Primary completion: 2024-04-01
• Completion: 2024-12-01
• First posted: 2015-02-27
• Last updated: 2023-04-18

Locations

1 site across 1 country: South Korea