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NCT05002595 Clinical Trial

H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

H. Pylori Infection Clinical Trial

Official title:
Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05002595
Other study ID # SCH-HP-2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2021

Study information
Verified date February 2022
Source Soonchunhyang University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment. Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

Description:

The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.

Recruitment information / eligibility
Status Completed
Enrollment 270
Est. completion date December 31, 2021
Est. primary completion date August 31, 2021
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 - History of gastric surgery - Recent history of upper gastrointestinal bleeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• H. pylori eradication
Antimicrobial agents for H. pylori eradication

Locations
Country Name City State
Korea, Republic of Digestive Disease Center, 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 infection status Rate of successful H. pylori eradication 6 weeks
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