Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication

H.Pylori Infection Clinical Trial

Official title:

Comparison of Helicobacter Pylori Eradication Rates Between Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based Triple Therapy: A Propensity Score Matching Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431737
• Other study ID #: SCH-HP-2024
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Soonchunhyang University Hospital
• Contact: Jun-Hyung Cho, M.D.
• Phone: +82-2-709-9202
• Email: chojhmd[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gastric acid depressant play a major role in an H. pylori eradication therapy by (1) increasing the intragastric pH, which improves antibiotic stability and bioavailability; (2) increasing the intragastric pH to 6 or more, which prompts H. pylori to replicate and thus become more sensitive to antibiotics that are effective only against replicating bacteria, such as amoxicillin; (3) increasing the concentration of antibiotics in the stomach. Of antimicrobial agents against H. pylori, amoxicillin is a penicillin derivative that inhibits the synthesis of the bacterial cell wall. Therefore, amoxicillin's bactericidal effect requires the bacteria to be replicating. Amoxicillin is excreted by the kidneys, the plasma half-life is approximately 1 hour, and the bactericidal effect is time dependent. Theoretically, amoxicillin should be given 3 or 4 times daily to maximize the time above minimal inhibitory concentration (MIC) However, in most H. pylori eradication therapies, amoxicillin is given twice daily, where the estimated time above MIC attained by twice daily dosing is insufficient for amoxicillin. Because most strains of H. pylori are sensitive to amoxicillin, 3 or 4 times daily administration may be appropriate to increase the H. pylori eradication success. Nevertheless, data regarding the amoxicillin dosing interval for successful H. pylori eradication are lacking.

Description:

The investigators aim to compare the H. pylori eradication rates between twice- and four-times-daily amoxicillin administration in 2-week tegoprazan-based triple therapy. Secondary outcomes are treatment compliance and drug-related adverse event rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• H.Pylori Infection

Intervention

Drug:
• Amoxicillin
Tegoprazan 50 mg bid, amoxicillin 1000 mg bid or 500 mg qid, clarithromycin 500 mg bid for 14 days

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori eradication rates	Urea breath test after completing H. pylori eradication regimen	6 weeks
Secondary	Treatment compliance	Assessment of patients' numbers completing H. pylori eradication regimen	6 weeks
Secondary	Drug-related adverse event rate	Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment	6 weeks