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Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

Analysis of Gut Microbiota, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor -α, Interleukin-10, and Foxp3 in Psoriasis Vulgaris After Supplementation With Lactobacillus Plantarum IS-10506

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05254249
Enrollment
75
Registered
2022-02-24
Start date
2022-02-07
Completion date
2022-10-31
Last updated
2022-02-24

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

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis Vulgaris, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor- A, Interleukin-10, Foxp3, Lactobacillus Plantarum IS-10506, Gut Microbiota

Brief summary

Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs. The provision of probiotic Lactobacillus plantarum IS-10506, an Indonesian original probiotic strain, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia. This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.

Detailed description

Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs. Psoriasis can increase the incidence of other diseases such as joint disorders, cardiovascular disorders, and psychological. Symptoms of psoriasis on the skin are red, well-defined plaques covered with thick, white, layered scales. The incidence of psoriasis is quite large, known to affect 0.09 - 11.4% of the world's population with rates varying between regions. Data in Indonesia is estimated that there are 2-6 million psoriasis sufferers in 2010, with a prevalence range of 1-3% in several teaching hospitals. During the period from 2016 to 2018, psoriasis vulgaris patients in the outpatient unit of RSUD Dr. Soetomo Surabaya recorded as many as 208 or 0.46% of all skin patients. One of the mechanisms of psoriasis is abnormalities in Treg cells (cells that play a role in expressing Foxp3), resulting in an imbalance in the immune system with the dominance of T helper 1 (Th1) and T helper 17 (Th17) cells. In addition, the composition of the gut microbiota (collection of bacteria) in psoriasis patients is different from that of healthy people. The composition of the gut microbiota can be influenced by race, geography, and eating habits. Until now there has been no report on the intestinal microbiota profile of psoriasis patients in Indonesia. The provision of probiotic Lactobacillus plantarum IS-10506, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia. Lactobacillus plantarum IS-10506 is produced from Dadih, a traditional fermented milk from West Sumatra, Indonesia. This probiotic is expected to be most compatible with the composition of the gut microbiota of Indonesians because it comes from an environment with similar exposure to pathogenic bacteria. This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.

Interventions

Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU

OTHERPlacebo

Placebo is an empty drug, given in capsule form with a dose of 2x1 sachets

Sponsors

Universitas Airlangga
CollaboratorOTHER
Dr. Soetomo General Hospital
Lead SponsorOTHER_GOV

Study design

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

Masking description

Probiotic and placebo packaging are made the same, and drug code is randomized by pharmacy

Intervention model description

A double blinded randomized clinical trial using a prospective cohort method in psoriasis vulgaris patients with purposive sampling.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

Patient Group Inclusion Criteria: 1. Psoriasis vulgaris patients with or without treatment 2. Mild to moderate degree 3. Age 18-70 years old 4. Willing to give informed consent Healthy Control Group Inclusion Criteria: 1. Undiagnosed as Psoriasis 2. Body mass index (BMI) is matched with the patient group 3. Age 18-70 years old 4. Willing to give Informed Consent

Exclusion criteria

Patient Group

Design outcomes

Primary

MeasureTime frameDescription
Alpha and beta12 weeksAlpha and beta diversity in gut microbiota profiles
Serum levels12 weeksChanges in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method
PASI scores12 weeksChanges in PASI scores after the intervention

Secondary

MeasureTime frameDescription
DLQI12 weeksChanges in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires

Countries

Indonesia

Contacts

Primary ContactMenul Ayu Umborowati, Specialist
menulayu@gmail.com+6281328859509

Outcome results

None listed

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