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

April 13, 2026 updated by: Foundation University Islamabad

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Arfan ul Bari, FCPS Derma
  • Phone Number: +923016547007
  • Email: albariul@gmail.com

Study Contact Backup

  • Name: Dr. Aima Tariq, FCPS, Fellowship in Derma
  • Phone Number: +923359844189
  • Email: aimatariq1@gmail.com

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46000
        • Fauji Foundation Hospital, Rawalpindi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aima Tariq, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: 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.
Placebo Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean reduction in total acne lesion count
Time Frame: 12 weeks
Reduction in total acne lesion count from baseline to 12 weeks, assessed using standardized lesion counting and Global Acne Grading System (GAGS).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean reduction in serum Interleukin-6 (IL-6) levels
Time Frame: Baseline to 12 weeks
Change in serum IL-6 levels from baseline to Week 12, measured using ELISA. Greater reduction indicates decreased systemic inflammation.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Collaborators

Fauji Foundation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 7. Lee YB, Byun EJ, Kim HS. Potential role of the microbiome in acne: a comprehensive review. J Clin Med. 2019.
  • 6. Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006 e1-1006 e30.
  • 5. 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.
  • 4. 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.
  • 3. 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.
  • 2. 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.
  • 1. Warp PV, Bilik SM, Ferrari LM, Keri JE. Prebiotics, Probiotics, and Postbiotics for Acne Vulgaris: A Systematic Review. Dermatol Ther (Heidelb). 2026 Feb 17.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUMCRCT7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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