ProbioticNCT07277075
Probiotic Intervention and Its Influence on Serum Leucine-Rich Alpha-2 Glycoprotein 1 Levels in Acne Vulgaris Patients
An observational study of Probiotic and Influence, run by Benha University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Probiotic, Influence, Serum Leucine-Rich Alpha-2 Glycoprotein 1
- What is being tested?
- Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levelDiagnostic test
Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levels were assessed in acne vulgaris participants and healthy controls.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Participants with clinically diagnosed mild to moderate acne vulgaris (AV) based on the Glycosaminoglycans (GAGs). Receives: Diagnostic Test: Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level | |
| Control group | Apparently healthy controls matched for age and sex Receives: Diagnostic Test: Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Leucine-Rich Alpha-2 Glycoprotein 1 Level
Serum Leucine-Rich Alpha-2 Glycoprotein 1 Level was assessed.
Measured: 12 weeks after the therapy
Secondary outcomes (2)
Acne severity
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"
Measured: 12 weeks after the therapy
Patient satisfaction
Patient satisfaction was evaluated using the Likert scale, with response options ranging from 1 = very dissatisfied to 5 = very satisfied.
Measured: 12 weeks after the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Oct 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Ali Awad Menesy, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277075
- Sponsor's protocol ID
- 40-10-2024
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Intervention and Its Influence on Serum Leucine-Rich Alpha-2 Glycoprotein 1 Levels in Acne Vulgaris Patients
- ClinicalTrials.gov ID
- NCT07277075
- Acronym / sponsor ID
- 40-10-2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levelParticipants with clinically diagnosed mild to moderate acne vulgaris (AV) based on the Glycosaminoglycans (GAGs). |
| Control group | – | Diagnostic Test: Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levelApparently healthy controls matched for age and sex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- Pregnancy.
- Lactation.
- History of hypersensitivity to probiotic components.
- Smoking.
- Presence of infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levelSerum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levels were assessed in acne vulgaris participants and healthy controls. | Diagnostic test | Control group, Study group |
Primary outcome
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.
2 secondary outcomes
Acne severity
Time frame: 12 weeks after the therapy
Patient satisfaction
Time frame: 12 weeks after the therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Probiotic and Influence, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Leucine-Rich Alpha-2 Glycoprotein 1 Level (time frame: 12 weeks after the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.