Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT05453994
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bismuth for PCAB-based H. Pylori Eradication
Sponsor:
Soonchunhyang University Hospital
Organization:
Study Overview
Official Title:
Efficacy of Bismuth Added to Potassium-competitive Acid Blocker-based Triple Regimen for First-line Helicobacter Pylori Eradication
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: