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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSeoul National University Bundang Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

The patients who proved H. pylori infection following three methods

positive rapid urease test (CLOtest)

histologic evidence of H. pylori by modified Giemsa staining

positive Urea breath test

Disqualifiers

Patients who received eradication therapy for H. pylori infection, previously

H. pylori eradication failure because of poor compliance

the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks

Advanced gastric cancer or other malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)

    Drug

    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).

  • 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)

    Drug

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

  • 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]

    Drug

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

  • 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)

    Drug

    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.

Treatment groups

600 Participants
are divided into 4 treatment groups
Group A: 10 day sequential groupActive comparator 1 intervention
Group B: 7 days tailored PPI triple therapy groupExperimental treatment 1 intervention
Group C: 7 days tailored MEA therapy groupExperimental treatment 1 intervention
Group D: 7 or 14 days tailored EBMT therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Compare the percentage of participants with successful H. pylori eradication in each groups

The efficacy of H. pylori eradication between a 7 days tailored therapy for H. pylori infection based on the results of antimicrobial resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 days therapy as first eradication regimen.

Time frame
6 weeks after completion of eradication

Secondary outcomes

Other outcomes

Sponsors and contacts

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