Optimal Tailored Treatment for H. Pylori Infection

NCT ID: NCT04462133

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-10-01

Brief 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.

Detailed 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.

Conditions

Helicobacter Pylori Infection; Antibiotic Resistant Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empirical therapy for H. pylori infection

The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIAGNOSTIC_TEST

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

Tailored therapy for H. pylori infection

The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR.

Group Type: EXPERIMENTAL

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Incheon St.Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joon Sung Kim

Assistant Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Byung-Wook Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Incheon St.Mary's Hospital

Locations

Incheon St. Mary's Hospital

Incheon, , South Korea

Countries

South Korea

Other Identifiers

XC20ENDT0022

Identifier Type: -

Identifier Source: org_study_id