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HELIUM: Helicobacter Pylori Prevalence in Southern Region of Romania

Sponsor
Carol Davila University of Medicine and Pharmacy (Other)
Overall Status
Recruiting
CT.gov ID
NCT05874960
Collaborator
(none)
1,300
Enrollment
1
Location
24
Anticipated Duration (Months)
54.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.

    The aim of the study is to evaluate the prevalence of H. pylori infection in several areas of the Southern Regions of Romania, considered as vulnerable pertaining to the access of health services.

    Fecal Helicobacter pylori will be tested, together with antibiotic susceptibility.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1300 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Helicobacter Pylori Prevalence in Southern Region of Romania
    Actual Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Mar 31, 2025
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Helicobacter pylori infection rate [12 months]

      rate of fecal antigen test divided by total number of tests (fecal Helicobacter test)

    Secondary Outcome Measures

    1. Antibiotic susceptibility rate [12 months]

      rate of antibiotic (x) susceptibility divided by total number of tests (antibiotic susceptibility test)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adult voluntary participants to "Medical services caravan" project by Medcorp Association
    Exclusion Criteria:

    • Age < 18 years old

    • No informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medcorp Association Bucharest Romania

    Sponsors and Collaborators

    • Carol Davila University of Medicine and Pharmacy

    Investigators

    • Principal Investigator: Radu Prodan, MD, Medcorp Association

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mihai Ciocirlan, Associate Professor, Carol Davila University of Medicine and Pharmacy
    ClinicalTrials.gov Identifier:
    NCT05874960
    Other Study ID Numbers:
    • HELIUM
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Helicobacter Infections

    Study Results

    No Results Posted as of May 25, 2023