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Bismuth for PCAB-based H. Pylori Eradication

NCT ID: NCT05453994

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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H. Pylori Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-bismuth group

Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days

H. pylori eradication

Intervention Type DRUG

PPIs-based Antimicrobial agents for H. pylori eradication

Bismuth group

Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days

H. pylori eradication

Intervention Type DRUG

PPIs-based Antimicrobial agents for H. pylori eradication

Interventions

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H. pylori eradication

PPIs-based Antimicrobial agents for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun-Hyung Cho

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun-Hyung Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

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Digestive Disease Center, Soonchunhyang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Cho JH. Bismuth add-on improves the efficacy of 2-week tegoprazan-based triple therapy for first-line Helicobacter pylori eradication: a real-world evidence study. Expert Rev Anti Infect Ther. 2024 Sep;22(9):793-799. doi: 10.1080/14787210.2024.2329251. Epub 2024 Mar 13.

Reference Type DERIVED
PMID: 38459869 (View on PubMed)

Other Identifiers

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SCH-HP-2022

Identifier Type: -

Identifier Source: org_study_id