The comparative study of 7 and 14 days bismuth-containing quadruple therapy as first line therapy for eradication of clarithromycin-resistant Helicobacter pylori

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0004414
• Lead Sponsor: The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Brief Summary

The overall eradication rates in intention-to-treat (ITT) and per-protocol (PP) analyses were 83.0% (95% CI 77.2–88.9%, 132/159) and 89.8% (95% CI 84.9–94.7%, 132/147), respectively. The eradication rates in the ITT analysis were 79.0% (95% CI 70.1–87.9%, 64/81) in the 7-day group and 87.2% (95% CI 79.8–94.6%, 68/78) in the 14-day group (p = 0.170). The eradication rates in the PP analysis were 86.5% (95% CI 78.7–94.3%, 64/74) in the 7-day group and 93.2% (95% CI 87.4–99.0%, 68/73) in the 14-day group (p = 0.182). Clinically significant adverse events occurred in 18.2% of subjects (95% CI 12.2–24.2%, 29/159). No statistically significant differences were found in the rates of individual adverse events or all adverse events between the two groups. Severe adverse events occurred in 4.4% of subjects (95% CI 1.2–7.6%, 7/159).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-15
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Patients over 19 year and below 75 year
- Patients with clarithromycin-resistant H. pylori-positive according to results of Dual Priming Oligonucleotide-Based Multiplex Polymerase Chain Reaction and biopsy
- Patients who agree to participate in this clinical trial and sign voluntarily
- Patients who don’t have dementia or cognitive impairment

Exclusion Criteria

- Those with the history of administration with other antibiotic within 1 month.
- The highly sensitive person to experimental drug
- Those who has undergone upper gastrointestinal surgery
- Those who take anticoagulant or steroids
- Liver disorder or renal disorder patients
- Pregnant or lactating women or childbearing women suspected pregnant
- Alcohol addictor or those with the history of drug abuse
- Those who participated in other clinical trial within 6 months before this clinical trial
- Those who are judged to be improper for this clinical trial

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rea breath test

Secondary Outcome Measures

Name	Time	Method
Adverse events