Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial

Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial - RCT comparing VA-VMS sequential and VAM HP eradication for Early age patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032109

Enrollment

190

Registered

2018-04-06

Start date

2018-09-01

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

A 14-day sequential therapy conaining vonoprazan and amoxicillin for 7 days followed by vonoprazan, metronidazole and sitafloxacin for 7 days : Vonoprazan 20mg bid Amoxicillin 750mg bid 7 days followe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) A patient with Helicobacter pylori infection. (2) A patient who can perform stool antigen test of Helicobacter pylori after 8 weeks from treatment completion. (3)A patient who give a written informed consent.

Exclusion criteria

Exclusion criteria: (1) A patient with history of Helicobacter pylori eradication. (2) Pregnancy. (3) Lactation. (4) Patients allergic to penicillin. (5) Past history of allergy for the drugs used in this study. (6) A patient with brain and spinal cord disease. (7) A patient with infectious mononucleosis. (8) Severe liver dysfunction, serere renal dysfunction, severe heart dysfunction. (9) Patient who is disualified for the study by physicians.

Design outcomes

Primary

Measure	Time frame
Eradication rate assessed by stool antigen test of Helicobacter pylori more than 8 weeks after treatment	—

Secondary

Measure	Time frame
Adverse event evaluated by side effect questionnaire filled by patients	—

Countries

Japan

Contacts

Public ContactSoichiro Sue

Yokohama City University Hospital Gastroenterology

ssue@yokohama-cu.ac.jp045-787-2326

Outcome results

None listed

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