NCT07539129

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Acne Vulgaris

Keywords

Acne VulgarisModrate AcneProbioticsInflammatory markersInterleukin 6Ecotec TM

Outcome Measures

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).

    12 weeks

Secondary Outcomes (1)

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

    Baseline to 12 weeks

Study Arms (2)

Oral Probiotics

EXPERIMENTAL

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

Oral Plecebo

PLACEBO COMPARATOR

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

Interventions

ProbioticsDIETARY_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.

Oral Probiotics
PlaceboOTHER

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.

Oral Plecebo

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital, Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (7)

  • 7. Lee YB, Byun EJ, Kim HS. Potential role of the microbiome in acne: a comprehensive review. J Clin Med. 2019.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Dr. Aima Tariq, FCPS, Fellowship in Derma

CONTACT

+923359844189aimatariq1@gmail.com

Dr. Arfan ul Bari, FCPS Derma

CONTACT

+923016547007albariul@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel-group randomized controlled trial. Participants with moderate acne vulgaris will be randomly assigned to either oral probiotics vs oral placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)