Bismuth for PCAB-based H. Pylori Eradication

NCT05453994 | Completed

• 1 other identifier: SCH-HP-2022
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• H. pylori infection status

  Rate of successful H. pylori eradication

  6 weeks

Study Arms (2)

Non-bismuth group

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

Drug: 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

Drug: H. pylori eradication

Interventions

H. pylori eradication DRUG

PPIs-based Antimicrobial agents for H. pylori eradication

Bismuth group; Non-bismuth group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

H. pylori-infected patients

You may qualify if:

• Gastroscopy can be performed
• H. pylori test and pathological analysis can be performed

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

Location

Related Publications (1)

• 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.

  PMID: 38459869 DERIVED

Study Officials

• Jun-Hyung Cho, M.D.

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 12, 2022
• Study Start: March 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)