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

Not Applicable

• Conditions: Helicobacter pylori infection

• Registration Number: JPRN-UMIN000021604
• Lead Sponsor: Yokohama City University Hospital

Brief Summary

The first-line eradication rates (ER) in the ITT and PP analyses were 84.9% and 86.4%, respectively, for VAC and 78.8% and 79.4%, respectively, for PAC. The ER of VAC was higher than that of PAC in the ITT (p=0.0061) and PP analyses (p=0.0013). In the second-line ITT and PP analyses VAM achieved ERs of 80.5% and 82.4%, respectively, while PAM achieved ERs of 81.5% and 82.1%, respectively. No significant differences were observed in the ITT (p=0.89) or PP (p=1.0) analyses.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-25
• Study Completion: 2020-06-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1593

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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