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A pilot study of Susceptibility testing based Fourth-line Helicobacter pylori eradication therapy

A pilot study of Susceptibility testing based Fourth-line Helicobacter pylori eradication therapy - Susceptibility based Fourth-line eradication

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025765
Enrollment
30
Registered
2017-01-22
Start date
2017-01-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

Vonoprazan 20mg bid Amoxicillin 500mg qid Clarithromycin 400mg bid Metronidazole 250mg bid 2 weeks This regimen is used with modification based on susceptibility testing.

Sponsors

Yokohama City University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A patient with Helicobacter pylori infection failed for first, second (one week triple therapy with acid suppressant and amoxicillin and clarithromycin or metronidazole) and sitafloxacin based third line eradication . A patient who was diagnosed for Helicobacter pylori infection by urea breath test or Helicobacter pylori stool antigen test. A patient who can perform urea breath test after 8 weeks from treatment completion. A patient who give a written informed consent.

Exclusion criteria

Exclusion criteria: A patient who don't agree for endoscopy and susceptible testing as own expense medical care before eradication therapy. Past history of allergy or side effect requiring treatment for the drugs used in this study. Pregnancy or lactation. A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patients who are disqualified for the study by physicians.

Design outcomes

Primary

MeasureTime frame
Eradication rate assessed by urea breath test more than 8 weeks after treatment

Secondary

MeasureTime frame
Safety evaluated by side effects questionnaire filled by patients

Countries

Japan

Contacts

Public ContactSoichiro Sue

Yokohama City University Hospital Gastroenterology

ssue@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026