Optimal Tailored Treatment for H. Pylori Infection

Not Applicable

Withdrawn

• Conditions: Helicobacter Pylori Infection; Antibiotic Resistant Infection
• Interventions: Diagnostic Test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)

• Registration Number: NCT04462133
• Lead Sponsor: Incheon St.Mary's Hospital

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.

Study Timeline

• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-07-04
• Study First Posted: 2020-07-08
• Study Start: 2020-09-01
• Primary Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empirical therapy for H. pylori infection	Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)	The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication
Tailored therapy for H. pylori infection	Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)	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.

Primary Outcome Measures

Name	Time	Method
Eradication success	8-12 weeks after eradication	H. pylori eradication success based on urea breath test

Trial Locations

Locations (1)

Incheon St. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of