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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-60
SponsorShenzhen People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactobacillus plantarum

    Biological/Vaccine

    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.

  • inactivated Lactobacillus plantarum

    Biological/Vaccine

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

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: group AExperimental treatment 1 intervention
Group B: group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Transepidermal Water Loss(TEWL)

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.

Time frame
The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.
2

General appearance photography

After shooting, three professional doctors will independently assess the improvement of psoriatic lesions in patients.

Time frame
The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.
3

Dermoscopic photography

After shooting, three professional doctors will independently assess the improvement of psoriatic lesions in patients.

Time frame
The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.
4

Completion of self-assessment questionnaires

Record the improvement of patients' self-perceived suboptimal skin conditions after treatment compared with the baseline.

Time frame
The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.

Secondary outcomes

Other outcomes

Sponsors and contacts

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