Probiotic Intervention and Its Influence on Serum Leucine-Rich Alpha-2 Glycoprotein 1 Levels in Acne Vulgaris Patients

November 29, 2025 updated by: Zeinab Ali Awad Menesy, Benha University
This study aimed to assess the serum level of Leucine-rich alpha-2 glycoprotein 1 (LRG1) in Acne vulgaris (AV) individuals and evaluate the effect of probiotic therapy on these serum levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acne vulgaris (AV) is a common inflammatory disorder of the pilosebaceous units, characterized by the presence of inflammatory, non-inflammatory, or a combination of both types of lesions.

Recent attention has turned toward biomarkers that reflect the inflammatory activity in acne and might act as indicators of disease severity, treatment response, or prognostic risk. One such candidate is Leucine-rich alpha-2 glycoprotein 1 (LRG1).

Probiotics are live microorganisms that, when administered in sufficient quantities, can modulate the composition of the gut microbiota, helping reduce microbial dysbiosis, regulate the immune response, and decrease inflammatory mediators, thereby reducing systemic inflammatory burden, which is called the gut-skin-axis relationship.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

  • Egypt
    • Benha
      • Banhā, Benha, Egypt, 13518
        • Benha University

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

No

Sampling Method

Non-Probability Sample

Study Population

This case-control study was conducted on all participants enrolled from the Dermatology & Andrology Outpatient Clinic at Benha University Hospital, Egypt, between October 2024 and September 2025.

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Both sexes.
  • Had not used systemic or topical acne therapy for at least two months or two weeks before the research, respectively.
  • Participants with clinically diagnosed mild to moderate acne vulgaris (AV) based on the Global Acne Grading System (GAGS)

Exclusion Criteria:

  • Pregnancy.
  • Lactation.
  • History of hypersensitivity to probiotic components.
  • Smoking.
  • Presence of infections.
  • Autoimmune or malignant diseases.
  • Receiving any systemic therapy likely to affect the microbiome or inflammatory biomarkers.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Participants with clinically diagnosed mild to moderate acne vulgaris (AV) based on the Glycosaminoglycans (GAGs).
Diagnostic test: Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level
Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levels were assessed in acne vulgaris participants and healthy controls.
Control group
Apparently healthy controls matched for age and sex
Diagnostic test: Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level
Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levels were assessed in acne vulgaris participants and healthy controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Leucine-Rich Alpha-2 Glycoprotein 1 Level
Time Frame: 12 weeks after the therapy
Serum Leucine-Rich Alpha-2 Glycoprotein 1 Level was assessed.
12 weeks after the therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acne severity
Time Frame: 12 weeks after the therapy
Acne severity was assessed based on Global Acne Grading System (GASA) score is considered as 1-18 "mild," 19-30 "moderate," 31-38 "severe," and >39 "very severe"
12 weeks after the therapy
Patient satisfaction
Time Frame: 12 weeks after the therapy
Patient satisfaction was evaluated using the Likert scale, with response options ranging from 1 = very dissatisfied to 5 = very satisfied.
12 weeks after the therapy

Collaborators and Investigators

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

Sponsor

Benha University

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)

October 1, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 29, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40-10-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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