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Completed

NCT Number: NCT05453994

Bismuth for PCAB-based H. Pylori Eradication

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.

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Key information

Conditions

H. Pylori Infection

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

H. pylori eradication

Drug

PPIs-based Antimicrobial agents for H. pylori eradication

Primary outcomes

  1. H. pylori infection status

    Time frame: 6 weeks

    Rate of successful H. pylori eradication

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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