Investigating the Efficacy of Oral Probiotics Versus Placebo in Pakistani Patients With Moderate Acne on Acne Lesion Count and Systemic Inflammation

ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-35
SponsorFoundation University Islamabad

About this trial

This randomized controlled trial evaluates the efficacy of oral probiotics compared to placebo in Pakistani patients with moderate Acne Vulgaris. Acne is a multifactorial inflammatory disorder influenced by microbial colonization, seborrhea, and immune dysregulation. Rising antibiotic resistance necessitates alternative therapeutic approaches. Emerging evidence highlights the gut-skin axis, suggesting probiotics may reduce systemic inflammation and acne severity. A total of 64 patients will be randomized into probiotic and placebo groups and treated for 12 weeks. The primary outcome is reduction in total acne lesion count, while the secondary outcome is change in serum Interleukin-6 levels. Clinical assessment includes lesion counts, GAGS scoring, and standardized photography. IL-6 levels will be measured using ELISA at baseline and study completion. Data will be analyzed using SPSS with appropriate statistical tests, considering p ≤ 0.05 as significant. This study aims to provide evidence for probiotics as a safe, effective, and antibiotic-sparing option in acne management, particularly in South Asian populations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients aged 15-35 years

Clinical diagnosis of moderate acne vulgaris

Fitzpatrick skin types III-V

Willing to provide informed consent and comply with study protocol

Disqualifiers

Severe nodulocystic acne, acne conglobata, or acne fulminans

Oral antibiotics, isotretinoin, or hormonal therapy within past 4 weeks

Topical anti-acne therapy within past 2 weeks

Current probiotic supplementation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotics

    Dietary supplement

    Participants will receive a standardized multi-strain oral probiotic (Ecotec sachet) once daily for 12 weeks alongside standard acne care. The formulation contains Lactobacillus and Bifidobacterium species aimed at modulating the gut-skin axis and reducing systemic inflammation.

  • Placebo

    Other intervention

    Participants will receive a placebo sachet identical in appearance, taste, and packaging to the probiotic, administered once daily for 12 weeks alongside standard acne care. The placebo contains inert ingredients with no active probiotic strains, ensuring blinding and allowing accurate comparison of treatment outcomes.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Oral ProbioticsExperimental treatment 1 intervention
Group B: Oral PleceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean reduction in total acne lesion count

Reduction in total acne lesion count from baseline to 12 weeks, assessed using standardized lesion counting and Global Acne Grading System (GAGS).

Time frame
12 weeks

Secondary outcomes

1

Mean reduction in serum Interleukin-6 (IL-6) levels

Change in serum IL-6 levels from baseline to Week 12, measured using ELISA. Greater reduction indicates decreased systemic inflammation.

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

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Foundation University Islamabad

Lead sponsor

Fauji Foundation Hospital

Collaborator

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