Prospective multicenter cohort study to evaluate the efficacy and safety of Helicobacter pylori eradication therapy

Prospective multicenter cohort study to evaluate the efficacy and safety of Helicobacter pylori eradication therapy - Prospective multicenter cohort study of H. pylori eradication

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021604

Enrollment

2000

Registered

2016-03-25

Start date

2015-05-26

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 750mg bid Clarithromycin 200mg or 400mg bid 1week Lansoprazole 30mg, Rabeprazole 10mg, Omeprazole 20mg,or Esomeprazole 20mg bid Amoxicillin 750mg bid Clarithromyci

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: <Prospective study> A patient with H.pylori infection. A patient who give a written informed consent. <Retrospective study> A patient who performed H. pylori eradication therapy in participation institutes of this study after November 2009. A patient who give informed consent as opt-out in each participation institutes of this study.

Exclusion criteria

Exclusion criteria: <Prospective study> A patient participating in UMIN000016335(PCAB-based H.pylori eradication study for patients with penicillin allergy), UMIN000016336(PCAB-based H.pylori third line eradication study), UMIN000016337(PCAB-based H.pylori first line eradication study), or UMIN000019628(Efficacy of UBT after PCAB-based H.pylori eradication) Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. Patients who are disqualified for the study by physicians. <Retrospective study> A patient participating in UMIN000016335(PCAB-based H.pylori eradication study for patients with penicillin allergy), UMIN000016336(PCAB-based H.pylori third line eradication study), UMIN000016337(PCAB-based H.pylori first line eradication study), or UMIN000019628(Efficacy of UBT after PCAB-based H.pylori eradication)

Design outcomes

Primary

Measure	Time frame
Comparison of eradication rate by 1) Regimens (P-CAB/AMPC/CAM 1week, PPI/AMPC/CAM 1week, P-CAB/AMPC/MNZ 1week, P-CAB/AMPC/MNZ 1week, etc.) 2) Eradication number of times (first line, second line, etc.) 3) prospective, retrospective 4) Antibiotic-resistance of H. pylori (CAM resistance, MNZ resistance, etc.) 5) Another factors that affect the eradication (smoking etc.). Success of eradication was assessed by urea breath test or H. pylori stool antigen test more than 4 weeks after treatment	—

Measure

Time frame

Comparison of eradication rate by 1) Regimens (P-CAB/AMPC/CAM 1week, PPI/AMPC/CAM 1week, P-CAB/AMPC/MNZ 1week, P-CAB/AMPC/MNZ 1week, etc.) 2) Eradication number of times (first line, second line, etc.) 3) prospective, retrospective 4) Antibiotic-resistance of H. pylori (CAM resistance, MNZ resistance, etc.) 5) Another factors that affect the eradication (smoking etc.). Success of eradication was assessed by urea breath test or H. pylori stool antigen test more than 4 weeks after treatment

—

Secondary

Measure	Time frame
1)Safety evaluated by side effects questionnaire filled by patients during therapy 2)Rate of post-eradication gastric carcinogenesis, reinfection of H. pylori, and factors affecting them	—

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