RecruitingNot ApplicableNCT02373280

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

Sponsor

Seoul National University Bundang Hospital

Enrollment

600 participants

Start Date

Aug 1, 2014

Study Type

INTERVENTIONAL

Conditions

Helicobacter Infection

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole), a drug called 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin], and others for people with helicobacter infection. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG10 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).

DRUG7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)

the participants received PPI based triple therapy\[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\]

DRUG7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]

moxifloxacin triple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)\].

DRUG7 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.

Locations(1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

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NCT02373280

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