H. Pylori Treatment Between Modified Quadruple Regimen an... | NCT05002595

Studies
H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

NCT05002595

Sponsor

Soonchunhyang University Hospital

Status

Completed

Last Update Posted

Feb 24, 2022Actual

Enrollment

270Actual

Phase

Not provided

Conditions

H. Pylori Infection

Interventions

H. pylori eradication

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Aug 4, 2021

First Submission Date that Met QC Criteria

Aug 4, 2021

First Posted Date

Aug 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2022

Last Update Posted Date

Feb 24, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun-Hyung Cho, Associate Professor, Soonchunhyang University HospitalPrincipal Investigator

Lead Sponsor

Soonchunhyang University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.

Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

Detailed Description

The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

270Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Modified quadruple therapy		pantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days	Drug: H. pylori eradication
Tailored eradication		pantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 days	Drug: H. pylori eradication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
H. pylori eradication	Drug	Antimicrobial agents for H. pylori eradication	Modified quadruple therapy Tailored eradication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
H. pylori infection status	Rate of successful H. pylori eradication	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gastroscopy can be performed
H. pylori test and pathological analysis can be performed

Exclusion Criteria:

Age < 20 or > 80 years
Anemia (serum hemoglobin level < 10 g/dL)
Severe systemic disease
Advanced chronic liver disease
Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
History of H. pylori eradication
History of gastric surgery
Recent history of upper gastrointestinal bleeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

H. pylori-infected patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun-Hyung Cho, M.D.	Soonchunhyang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Disease Center, Soonchunhyang University Hospital		Seoul		04401	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34883037	Derived	Cho JH, Jin SY, Park S. Comparison of tailored Helicobacter pylori eradication versus modified bismuth quadruple therapy in Korea: a randomized controlled trial. Expert Rev Anti Infect Ther. 2022 Jun;20(6):923-929. doi: 10.1080/14787210.2022.2017280. Epub 2021 Dec 20.