Optimal Tailored Treatment for H. Pylori Infection
Primary Purpose
Helicobacter Pylori Infection, Antibiotic Resistant Infection
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Empirical therapy for H. pylori infection
Tailored therapy for H. pylori infection
Arm Description
The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication
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.
Outcomes
Primary Outcome Measures
Eradication success
H. pylori eradication success based on urea breath test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04462133
Brief Title
Optimal Tailored Treatment for H. Pylori Infection
Official Title
Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Incheon St.Mary's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Antibiotic Resistant Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Empirical treatment versus tailored therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1988 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Empirical therapy for H. pylori infection
Arm Type
Active Comparator
Arm Description
The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication
Arm Title
Tailored therapy for H. pylori infection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
Intervention Description
Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results
Primary Outcome Measure Information:
Title
Eradication success
Description
H. pylori eradication success based on urea breath test
Time Frame
8-12 weeks after eradication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byung-Wook Kim, MD, PhD
Phone
82-32-280-5057
Email
gastro@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Wook Kim, MD, PhD
Organizational Affiliation
Incheon St.Mary's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimal Tailored Treatment for H. Pylori Infection
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