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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04462133
Other study ID # XC20ENDT0022
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date October 1, 2024

Study information

Verified date May 2024
Source Incheon St.Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Patients are randomly assigned to the empirical therapy group and tailored therapy group. The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results. Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 1, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 79 Years
Eligibility Inclusion Criteria: - consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection Exclusion Criteria: - subjects younger than 18 years old - subjects with a history of H pylori eradication - subjects who had previous gastric surgery - subjects who were pregnant or lactating - subjects with serious concurrent illness - subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study - subjects with a history of allergy to any one of the compounds in this study

Study Design


Intervention

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

Locations

Country Name City State
Korea, Republic of Incheon St. Mary's Hospital Incheon

Sponsors (1)

Lead Sponsor Collaborator
Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eradication success H. pylori eradication success based on urea breath test 8-12 weeks after eradication
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