MedTrace Logo

Optimal Tailored Treatment for H. Pylori Infection

NCT04462133 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-05-16

No results posted yet for this study

Summary

The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.

Conditions

  • Helicobacter Pylori Infection
  • Antibiotic Resistant Infection

Interventions

DIAGNOSTIC_TEST

Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)

Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results

Sponsors & Collaborators

  • Incheon St.Mary's Hospital

    lead OTHER

Principal Investigators

  • Byung-Wook Kim, MD, PhD · Incheon St.Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-03-31
Completion
2024-10-01

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462133 on ClinicalTrials.gov