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NCT05453994 Clinical Trial

Bismuth for PCAB-based H. Pylori Eradication

H. Pylori Infection Clinical Trial

Official title:
Efficacy of Bismuth Added to Potassium-competitive Acid Blocker-based Triple Regimen for First-line Helicobacter Pylori Eradication

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05453994
Other study ID # SCH-HP-2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date August 31, 2023

Study information
Verified date November 2023
Source Soonchunhyang University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB. Bismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication rate by 30%-40% in resistant H. pylori strains.

Description:

The investigators aim to evaluate the success rate and adverse drug events of bismuth added to PCAB-based triple therapy as a first-line regimen for H. pylori infection.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Gastroscopy can be performed - H. pylori test and pathological analysis can be performed Exclusion Criteria: - Age < 20 or > 80 years - Anemia (serum hemoglobin level < 10 g/dL) - Severe systemic disease - Advanced chronic liver disease - Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics - History of H. pylori eradication - Drug allergy to antibiotics - History of gastric surgery - Recent history of upper gastrointestinal bleeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• H. pylori eradication
PPIs-based Antimicrobial agents for H. pylori eradication

Locations
Country Name City State
Korea, Republic of Digestive Disease Center, Soonchunhyang University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary H. pylori infection status Rate of successful H. pylori eradication 6 weeks
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