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Bismuth for PCAB-based H. Pylori Eradication

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05453994
Enrollment
150
Registered
2022-07-12
Start date
2020-03-01
Completion date
2023-08-31
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H. Pylori Infection

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.

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.

Interventions

PPIs-based Antimicrobial agents for H. pylori eradication

Sponsors

Soonchunhyang University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
H. pylori infection status6 weeksRate of successful H. pylori eradication

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026