Helicobacter Pylori Prevalence in Southern Region of Romania | NCT05874960

Studies
Helicobacter Pylori Prevalence in Southern Region of Romania

NCT05874960

Sponsor

Carol Davila University of Medicine and Pharmacy

Status

Completed

Last Update Posted

Aug 21, 2024Actual

Enrollment

708Actual

Phase

Not provided

Conditions

Infections, Helicobacter

Interventions

Not provided

Countries

Romania

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

Aug 2024

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

Apr 1, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

May 16, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 25, 2023Actual

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

Aug 20, 2024

Last Update Posted Date

Aug 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mihai Ciocirlan, Associate Professor, Carol Davila University of Medicine and PharmacyPrincipal Investigator

Lead Sponsor

Carol Davila University of Medicine and PharmacyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

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.

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

708Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age < 18 years old
No informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Radu Prodan, MD	Medcorp Association	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medcorp Association		Bucharest			Romania

Condition Browse Module

MeSH Terms

ID	Term
D016481	Helicobacter Infections

Ancestor Terms

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided