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Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial

Evaluating the Safety and Efficacy of Lactobacillus Plantarum in Treating Psoriasis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07194200
Enrollment
184
Registered
2025-09-26
Start date
2025-12-15
Completion date
2026-06-30
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactobacillus Plantarum, Psoriasis

Keywords

psoriasis, Lactobacillus plantarum

Brief summary

A growing body of evidence indicates that the pathogenesis of psoriasis may be closely linked to skin microbiome dysbiosis. Compared with healthy individuals, the composition and function of the skin microbiota in psoriasis patients exhibit significant alterations5,6. This microbial imbalance is thought to contribute to the initiation and progression of the disease through mechanisms such as triggering abnormal immune responses, exacerbating inflammatory processes, and impairing the skin barrier. In-depth exploration of the interplay between psoriasis and the microbiome not only offers new perspectives for elucidating the disease's pathogenesis but also lays the groundwork for developing innovative microbiota-targeted diagnostic and therapeutic strategies. Thus, identifying novel therapeutic approaches that bridge psoriasis treatment and microbial regulation holds substantial clinical and social value. While existing treatments for psoriasis have made some progress, research specifically focusing on the microbiota-psoriasis relationship remains relatively limited. Investigating the intrinsic connections between microecological balance and psoriasis management, and developing practical improvement strategies, is therefore of crucial practical significance for enhancing skin health and improving quality of life. This study aims to address this research gap and provide a new therapeutic option for individuals with psoriasis.

Interventions

Intervention measures for the experimental group: Apply 5ml of Lactobacillus plantarum solution extracted from the skin surface of healthy individuals to the psoriatic lesions daily, for a duration of 2 months.

BIOLOGICALinactivated Lactobacillus plantarum

Intervention measures for the control group: Apply 5ml of inactivated Lactobacillus plantarum solution to the psoriatic lesions daily, for a duration of 2 months.

Sponsors

Shenzhen People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Intervention measures for the experimental group: Apply 5ml of Lactobacillus plantarum solution extracted from the skin surface of healthy individuals to the psoriatic lesions daily, for a duration of 2 months. Intervention measures for the control group: Apply 5ml of inactivated Lactobacillus plantarum solution to the psoriatic lesions daily, for a duration of 2 months.

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Reference to Psoriasis Area and Severity Index (PASI) score \< 10 Patients have been informed of the study details, voluntarily participate, and have signed the informed consent form; Aged 18-60 years with good general health status; No use of any medications within 6 months; No various inflammatory or immune skin diseases, no local infections, and no neuromuscular diseases.

Exclusion criteria

* Patients with other types of psoriasis or severe psoriasis; Those in the active phase of skin diseases or with other serious diseases; Other situations deemed unsuitable for enrollment by the researchers, such as subjects who are untrustworthy, unable to accept or understand the study assessments.

Design outcomes

Primary

MeasureTime frameDescription
Completion of self-assessment questionnairesThe follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.Record the improvement of patients' self-perceived suboptimal skin conditions after treatment compared with the baseline.
Adverse reactionsThe follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.Subjects will record predefined expected post-treatment events at the treated sites.
Transepidermal Water Loss(TEWL)The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.Use a dermatological detector to measure the TEWL of the skin. Gently press the probe against the subject's skin, and the TEWL at that location will be displayed on the device's screen.
General appearance photographyThe follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.After shooting, three professional doctors will independently assess the improvement of psoriatic lesions in patients.
Dermoscopic photographyThe follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.After shooting, three professional doctors will independently assess the improvement of psoriatic lesions in patients.

Countries

China

Contacts

Primary ContactJianglin Zhang
zhang.jianglin@szgospital.com+86 13873143466
Backup Contactzhen lin
+86 13588142362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026