ClinicalTrials.gg
RecruitingNCT07194200Updated Dec 24, 2025

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

A Phase 2 interventional study of Lactobacillus plantarum and inactivated Lactobacillus plantarum in Psoriasis and Lactobacillus Plantarum, sponsored by Shenzhen People's Hospital. Recruiting at 1 site in China. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Shenzhen People's Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Lactobacillus Plantarum

Browse trials for

Keywords

  • psoriasis
  • Lactobacillus plantarum
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 184 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Shenzhen People's Hospital is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
184 participants (estimated)

Study arms

  • Experimental
    group A

    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.

    Biological: Lactobacillus plantarum

  • Active comparator
    group B

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

    Biological: inactivated Lactobacillus plantarum

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.

06

What researchers measure

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.

  5. Adverse reactions

    Subjects will record predefined expected post-treatment events at the treated sites.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07194200
Lead sponsor
Shenzhen People's Hospital
Responsible party
Sponsor
First posted
Sep 26, 2025
Start date
Dec 15, 2025
Primary completion
Jun 25, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Dec 24, 2025

Study contacts

Jianglin Zhang
Contact
zhang.jianglin@szgospital.com
+86 13873143466
zhen lin
Contact
+86 13588142362

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lactobacillus plantarum

Start the discussion