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临床试验/NCT07194200
NCT07194200招募中2 期

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

Shenzhen People's Hospital1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2025年12月15日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
184
试验地点
1
主要终点
Transepidermal Water Loss(TEWL)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

group A

Experimental

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.

干预措施: Lactobacillus plantarum (Biological)

group B

Active Comparator

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

干预措施: inactivated Lactobacillus plantarum (Biological)

结局指标

主要结局

Transepidermal Water Loss(TEWL)

时间窗: 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 photography

时间窗: The 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 photography

时间窗: The 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.

Completion of self-assessment questionnaires

时间窗: The 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 reactions

时间窗: The 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.

次要结局

未报告次要终点

研究者

发起方
Shenzhen People's Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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