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Completed

NCT Number: NCT07277075

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University

Banhā, Benha, 13518, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level

Diagnostic Test

Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levels were assessed in acne vulgaris participants and healthy controls.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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"

  2. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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