NCT05247112

Brief Summary

To assess antimicrobial resistance rates and minimal inhibitory concentrations in H. pylori isolated from patients with upper gastrointestinal disease with long-term period.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jul 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jul 2003Dec 2027

Study Start

First participant enrolled

July 1, 2003

Completed
18.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

24.5 years

First QC Date

January 18, 2022

Last Update Submit

April 12, 2023

Conditions

Helicobacter Pylori InfectionHelicobacter Pylori Associated Gastrointestinal DiseaseHelicobacter Pylori Infection, Susceptibility toHelicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation

Keywords

eradicationrescue therapyantibioticsresistanceHelicobacter pylori

Outcome Measures

Primary Outcomes (3)

  • Resistance rate

    It means resistance to an antimicrobial agent applicable for H. pylori eradication. Minimal inhibitory concentration test was performed for amoxicillin, clarithromycin, metronidazole, tetracycline, rifabutin, levofloxacin, and moxifloxacin using agar dilution method.

    through study completion, an average of 1 year

  • Minimal inhibitory concentration (MIC) distribution

    The concentration of specific antibiotics that can kill 50% of H. pylori is defined as MIC50. Each analyzes the ratio of strain according to the concentration of antibiotics.

    through study completion, an average of 1 year

  • Multiple resistance, prevalance and trends

    It is defined as the case where the H. pylori strain shows resistance to several antimicrobial agents at the same time. Multiple resistance is calculated by calculating the proportion of strains with simultaneous resistance to 1\> clarithromycin and metronidazole, 2\> clarithromycin and fluoroquinolone, and 3\> clarithromycin, fluoroquinolone, and metronidazole.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Risk factor for eradication failure or success

    through study completion, an average of 1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subjects of this study all had H. pylori infection. None of them should meet the exclusion criteria. Even though successfully proven H. pylori infection, culture procedures must be successful and the susceptibility must be clearly determined by obtaining MIC values to be finally included in this study. According to the literature, culture is successful at approximately 2/3. Informed consent will be obtained from all study subjects.

You may qualify if:

  • Subjects who had a H. pylori infection and had consented to undergo culture analysis via endoscopic resection, in order to determine the minimal inhibitory concentration (MIC) of various antibiotics.

You may not qualify if:

  • Patients with a concurrent critical illness, who abused drugs or alcohol, who were pregnant or nursing, or those who had received antibiotics, PPIs, or bismuth salts within 4 weeks, were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Related Publications (1)

  • Lee JW, Kim N, Choi SI, Jang JY, Song CH, Nam RH, Lee DH. Prevalence and trends of multiple antimicrobial resistance of Helicobacter pylori in one tertiary hospital for 20 years in Korea. Helicobacter. 2023 Feb;28(1):e12939. doi: 10.1111/hel.12939. Epub 2022 Dec 7.

    PMID: 36478622DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

H. pylori strains isolated by study subjects. Susceptibility is investigated for each of the H. pylori strains, and mutations (e.g., 23SrRNA, gyrA, etc.) that can decisively cause resistance can be investigated only if necessary. All consent to these biosamples will be obtained in advance.

Study Officials

  • Nayoung Kim, M.D., Ph.D

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Jung Won Lee, M.D.

CONTACT

+ 82-10-9356-7758saludos@naver.com

Nayoung Kim, M.D., Ph.D.

CONTACT

+ 82-31-787-7008nakim49@snu.ac.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 18, 2022

Study Start

July 1, 2003

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)