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CompletedNCT05874960HELIUMUpdated Aug 21, 2024

Helicobacter Pylori Prevalence in Southern Region of Romania

An observational study in Infections, Helicobacter, sponsored by Carol Davila University of Medicine and Pharmacy. Completed at 1 site in Romania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Carol Davila University of Medicine and Pharmacy · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
708
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Infections, Helicobacter
03

In context

Helicobacter Infections

186 studies on the registry are indexed under Helicobacter Infections; 32 are open to participants now.

This study's enrollment of 708 is above the median of 180 across 47 observational studies indexed under Helicobacter Infections.

Browse Helicobacter Infections studies →

Lead sponsor

Carol Davila University of Medicine and Pharmacy is the lead sponsor of 25 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult population from Southern Regions of Romania, from rural vulnerable areas concerning access to health services.

Inclusion criteria

  • Adult voluntary participants to "Medical services caravan" project by Medcorp Association

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years old
  • No informed consent
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Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
708 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Helicobacter pylori infection rate

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

    Time frame: 12 months

Secondary outcomes

  1. Antibiotic susceptibility rate

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

    Time frame: 12 months

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Study locations

1 site
  • Medcorp Association
    Bucharest, Romania
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05874960
Lead sponsor
Carol Davila University of Medicine and Pharmacy
Responsible party
Mihai Ciocirlan (Associate Professor, Carol Davila University of Medicine and Pharmacy) — Principal investigator
First posted
May 25, 2023
Start date
Apr 1, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Aug 21, 2024

Study contacts

Radu Prodan, MD
principal investigator · Medcorp Association

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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