Skip to content

H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05002595
Enrollment
270
Registered
2021-08-12
Start date
2018-01-01
Completion date
2021-12-31
Last updated
2022-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H. Pylori Infection

Brief 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.

Detailed 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.

Interventions

Antimicrobial agents for H. pylori eradication

Sponsors

Soonchunhyang University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
H. pylori infection status6 weeksRate of successful H. pylori eradication

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026