Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus

August 28, 2026 updated by: Renad Mohammed Abdelhafez, Sohag University

Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus Isolates From Surgical Site Infections Exposed to Probiotic Cell-Free Supernatant

Staphylococcus aureus are Gram-positive cocci that asymptomatically colonize the skin and mucosal surfaces of approximately 20-30% of healthy individuals . Although they commonly exist as a harmless commensal organisms, S. aureus are one of the most clinically significant opportunistic pathogens, causing a wide range of community and healthcare-associated infections. These infections vary from superficial skin and soft tissue infections to severe invasive diseases, including bacteremia, infective endocarditis, pneumonia, osteomyelitis, and device-associated infections .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The global emergence and dissemination of methicillin-resistant Staphylococcus aureus (MRSA) have further complicated the treatment of these infections because of its resistance to β-lactam antibiotics and many other antimicrobial agents, leading to increased morbidity, mortality, prolonged hospitalization, and substantial healthcare costs worldwide.

The pathogenicity of Staphylococcus aureus is largely attributed to its diverse virulence factors, which facilitate bacterial adhesion, tissue invasion, immune evasion, and persistence within the host. These virulence determinants include microbial surface components recognizing adhesive matrix molecule, extracellular enzymes, cytotoxins, superantigens, and immune evasion proteins, all of which contribute to successful colonization and disease progression .

Among these virulence factors, biofilm formation is considered one of the most important determinants of S. aureus pathogenicity. Biofilms are highly organized bacterial communities embedded within a self-produced extracellular polymeric matrix (EPS). This matrix enhances bacterial adherence to both biotic and abiotic surfaces while protecting the bacteria from host immune defenses and antimicrobial agents .

Consequently, biofilm-associated infections are often characterized by persistent infection, failure in treatment , and increased antimicrobial resistance, Therefore, disrupting biofilm formation has become a key target for developing novel therapeutic strategies.

Probiotics have attracted increasing attention as promising addition to conventional antimicrobial therapy because of their ability to inhibit pathogenic microorganisms, interfere with biofilm formation, and modulate bacterial virulence .

Many of these beneficial effects are mediated by probiotic-derived cell-free supernatants (CFS), which contain a variety of bioactive compounds, including organic acids, bacteriocins, hydrogen peroxide, biosurfactants, and other antimicrobial metabolites.

Several studies have demonstrated that probiotic-derived CFS can inhibit Staphylococcus aureus biofilm formation and suppress the expression of virulence-associated genes, thereby reducing bacterial pathogenicity .

Surgical site infections (SSIs) represent a major healthcare burden in Egyptian hospitals, with reported prevalence rates ranging from 9% to 26% among postoperative patients .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

wound swabs and pus specimens will be collected under complete aseptic conditions from patients with suspected SSIs using sterile swabs. The samples will be transferred immediately to the microbiology laboratory to be processed

Description

Inclusion Criteria:

  • Patients of any age diagnosed with postoperative SSIs.
  • Clinical isolates from SSIs identified as MRSA.

Exclusion Criteria:

  • Any microorganism isolated from SSIs other than MRSA.
  • Prior administration of postoperative antibiotics

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The effect of Probiotic cell-free supernatant (CFS) on the expression of the biofilm-associated genes icaA and fnbA in clinical MRSA isolates..
Time Frame: December 2026- to March 2027
December 2026- to March 2027
The number of clinical Staphylococcus aureus isolates from SSIs and determine their antimicrobial susceptibility patterns to identify methicillin-resistant Staphylococcus aureus (MRSA).
Time Frame: September 2026 to January 2027
September 2026 to January 2027
The effect of Probiotic cell-free supernatant (CFS) on the expression of the antibiotic resistance-associated genes mecA and femA in clinical MRSA isolates
Time Frame: March 2027 to June 2027
March 2027 to June 2027

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-26-8-19MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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