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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Probiotics
Dietary supplementParticipants 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 interventionParticipants 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
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Sponsors and contacts
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Foundation University Islamabad
Lead sponsor
Fauji Foundation Hospital
Collaborator
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