Helicobacter Pylori Prevalence in Southern Region of Romania (HELIUM)

May 16, 2023 updated by: Mihai Ciocirlan, Carol Davila University of Medicine and Pharmacy
Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years old
  • No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter pylori infection rate
Time Frame: 12 months
rate of fecal antigen test divided by total number of tests (fecal Helicobacter test)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic susceptibility rate
Time Frame: 12 months
rate of antibiotic (x) susceptibility divided by total number of tests (antibiotic susceptibility test)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carol Davila University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Radu Prodan, MD, Medcorp Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELIUM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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