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| Name | Class |
|---|---|
| Universitas Airlangga | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | 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. |
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| Placebo Group | Placebo Comparator | In the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks. |
|
| Healty Control Group | No Intervention | Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Plantarum IS-10506 | Drug | Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alpha and beta | Alpha and beta diversity in gut microbiota profiles | 12 weeks |
| Serum levels | Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method | 12 weeks |
| PASI scores | Changes in PASI scores after the intervention | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DLQI | Changes in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires | 12 weeks |
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Inclusion Criteria:
Patient Group Inclusion Criteria:
Healthy Control Group Inclusion Criteria:
Exclusion Criteria:
Patient Group Exclusion Criteria:
Healthy Control Group Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Menul Ayu Umborowati, Specialist | Contact | +6281328859509 | menulayu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Menul Ayu Umborowati, Specialist | Dr. Soetomo General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Airlangga | Recruiting | Surabaya | East Java | Indonesia |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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A double blinded randomized clinical trial using a prospective cohort method in psoriasis vulgaris patients with purposive sampling.
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Probiotic and placebo packaging are made the same, and drug code is randomized by pharmacy
| Placebo | Other | Placebo is an empty drug, given in capsule form with a dose of 2x1 sachets |
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| D019602 |
| Food and Beverages |