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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Probiotics
  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.
• Другое Placebo
  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.

Первичные конечные точки

• Mean reduction in total acne lesion count [Срок оценки: 12 weeks]

Вторичные конечные точки (1)

• Mean reduction in serum Interleukin-6 (IL-6) levels [Срок оценки: Baseline to 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Fauji Foundation Hospital, Rawalpindi — Rawalpindi

Публикации

• Lee YB, Byun EJ, Kim HS. Potential Role of the Microbiome in Acne: A Comprehensive Review. J Clin Med. 2019 Jul 7;8(7):987. doi: 10.3390/jcm8070987. PMID 31284694
• Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30. PMID 38300170
• Zhao Y, Yu C, Zhang J, Yao Q, Zhu X, Zhou X. The gut-skin axis: Emerging insights in understanding and treating skin diseases through gut microbiome modulation (Review). Int J Mol Med. 2025 Dec;56(6):210. doi: 10.3892/ijmm.2025.5651. Epub 2025 Oct 3. PMID 41041846
• Mohamed M, Ullah A, Hassan R, Hamza M, Mohamed I, Salam M. The Impact of Probiotics on Acne Vulgaris: A Meta-Analysis of Randomized Controlled Trials. Cureus. 2025 Nov 16;17(11):e97010. doi: 10.7759/cureus.97010. eCollection 2025 Nov. PMID 41416302
• Burckhardt-Bravo V, Funes-Ferrada R, Valenzuela F. Update on novel acne treatments: a narrative review focused on microbiome modulation and non-pharmacological approaches. An Bras Dermatol. 2026 Jan-Feb;101(1):501249. doi: 10.1016/j.abd.2025.501249. Epub 2026 Jan 15. PMID 41544313
• Ashkanani A, Ashkanani G, Yousef M, Rob M, Al-Marri M, Naseem N, Laws S, Chaari A. Microbiome and Skin Health: A Systematic Review of Nutraceutical Interventions, Disease Severity, Inflammation, and Gut Microbiota. Microorganisms. 2025 Dec 26;14(1):63. doi: 10.3390/microorganisms14010063. PMID 41597583
• Warp PV, Bilik SM, Ferrari LM, Keri JE. Prebiotics, Probiotics, and Postbiotics for Acne Vulgaris: A Systematic Review. Dermatol Ther (Heidelb). 2026 Mar;16(3):1531-1550. doi: 10.1007/s13555-026-01659-4. Epub 2026 Feb 17. PMID 41703218

Идентификаторы

NCT: NCT07539129 · FUMCRCT7

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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