Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Necrosis

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Other Dietary Supplements

All Drugs and Chemicals

Acidophilus

In the treatment group, intervention was given in the form of standard therapy and probiotic Lactobacillus plantarum IS 10605 in the amount of 2x1010 CFU for 12 weeks.

In the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks.

Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile.

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

Lactobacillus Plantarum IS-10506

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

Placebo

Menul Ayu Umborowati, Specialist

Menul Ayu Umborowati

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.

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.

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

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

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

Alpha and beta diversity in gut microbiota profiles

Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method

Changes in PASI scores after the intervention

Changes in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires

Universitas Airlangga

Dr. Soetomo General Hospital

doctor, dermatovenereologist

Behaviors and Mental Disorders

Musculoskeletal Diseases

Infections

Immune System Diseases

Digestive System Diseases

Heart and Blood Diseases

Depression

Arthritis, Psoriatic

Hypersensitivity

Weight Loss

Depressive Disorder

Communicable Diseases

Gastrointestinal Diseases

Suicidal Ideation

Body Weight

Vasculitis

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Apremilast

Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets

To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica

1. Planned registration period 2 years
2. Planned surveillance period for 4 years from 6 months after launch

Post-Marketing Surveillance Study of OTEZLA

OTEZLA® Tablets Drug Use-Results Survey

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Number of participants with adverse events

General Improvement Rating will be assessed by physician's observation

Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment.

PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner

The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire

Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris	NCT05254249	Psoriasis Vulga...	Lactobacillus P... Placebo	18 Years - 70 Years	Dr. Soetomo General Hospital
Post-Marketing Surveillance Study of OTEZLA	NCT03284879	Psoriasis		-	Amgen
Post-Marketing Surveillance Study of OTEZLA	NCT03284879	Psoriasis		-	Amgen
Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris	NCT05254249	Psoriasis Vulga...	Lactobacillus P... Placebo	18 Years - 70 Years	Dr. Soetomo General Hospital

Spots Global Cancer Trial Database for psoriasis vulgaris