A Randomized Controlled Trial Investigating the Efficacy of Oral Probiotics Versus Placebo in Pakistani Patients With Moderate Acne on Acne Lesion Count and Systemic Inflammation (Interleukin-6) Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Mean reduction in total acne lesion count
研究概览
简要总结
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.
详细描述
This randomized placebo-controlled trial evaluated the effectiveness of oral probiotics in patients with moderate acne vulgaris in Pakistan. Acne is a chronic inflammatory condition of the pilosebaceous unit with multifactorial pathogenesis involving sebum overproduction, follicular hyperkeratinization, microbial colonization, and inflammation. Conventional therapies, particularly antibiotics, are increasingly limited by resistance, prompting exploration of alternative treatments. Emerging evidence suggests a link between gut microbiota and skin inflammation, supporting the potential role of probiotics in acne management.
A total of 64 patients aged 18-35 years with moderate acne were enrolled and randomly assigned to receive either oral probiotic sachets or placebo once daily for 12 weeks. The probiotic preparation contained multiple strains including Lactobacillus and Bifidobacterium species. Baseline assessment included lesion counts, Global Acne Grading System scoring, and serum interleukin-6 levels. Follow-up evaluations were conducted at regular intervals to monitor clinical response, compliance, and adverse effects.
The primary outcome was reduction in total acne lesion count, while the secondary outcome was change in systemic inflammation measured by IL-6 levels. Blood samples were collected at baseline and at the end of treatment for cytokine analysis using ELISA. Standardized skincare was maintained for all participants to minimize confounding factors.
Data were analyzed using appropriate statistical tests, with significance set at p ≤ 0.05. Ethical approval was obtained, and informed consent was secured from all participants. The study aimed to determine whether probiotics could provide a safe and effective adjunct or alternative to conventional acne therapies by reducing both clinical severity and systemic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study is assessor-blinded: participants are aware of the assigned treatment (oral probiotic or placebo), but the investigator assessing outcomes (acne lesion count, GAGS score, and IL-6 levels will be blinded to group allocation.
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Chronic inflammatory or autoimmune disease
- •Pregnancy or lactation
研究组 & 干预措施
Oral Probiotics
Participants receive oral probiotic sachets (Ecotec®) once daily for 12 weeks. Each sachet contains a combination of Lactobacillus acidophilus, Bifidobacterium species, Streptococcus thermophilus, and Lactobacillus delbrueckii. The sachet is dissolved in water and taken after meals.Describe the intervention(s) to be administered.
For drugs use generic name and include dosage form, dosage, frequency and duration.
干预措施: Probiotics (Dietary Supplement)
Oral Plecebo
Participants receive a placebo sachet identical in appearance, taste, and packaging to the probiotic, administered once daily for 12 weeks. The placebo contains inactive ingredients with no therapeutic effect.
干预措施: Placebo (Other)
结局指标
主要结局
Mean reduction in total acne lesion count
时间窗: 12 weeks
Reduction in total acne lesion count from baseline to 12 weeks, assessed using standardized lesion counting and Global Acne Grading System (GAGS).
次要结局
- Mean reduction in serum Interleukin-6 (IL-6) levels(Baseline to 12 weeks)