Clinical trial NCT05254249: Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
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
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Universitas Airlangga
First posted: 2022-02-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double blinded randomized clinical trial using a prospective cohort method in psoriasis vulgaris patients with purposive sampling.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 Exclusion Criteria:

1. Patients on systemic treatment with corticosteroids, methotrexate, cyclosporine, or biologic agents within 3 months prior to sampling
2. Take oral antibiotics, laxatives, and proton pump inhibitors (PPI) within 14 days before stool sampling
3. Suffering from severe systemic disease, diarrhea
4. Pustular psoriasis patients
5. Take probiotics within 30 days before stool sampling

Healthy Control Group Exclusion Criteria:

1. Patients on systemic treatment with corticosteroids, methotrexate, cyclosporine, or biologic agents within 3 months before stool sampling
2. Take oral antibiotics, laxatives, and proton pump inhibitors (PPI) within 14 days before stool sampling
3. Suffering from severe systemic disease, diarrhea

Primary outcomes:
measure: Alpha and beta
timeFrame: 12 weeks
measure: Serum levels
timeFrame: 12 weeks
measure: PASI scores
timeFrame: 12 weeks
Secondary outcomes:
measure: DLQI
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Universitas Airlangga
state: Jawa Timur
Study officials:
affiliation: Dr. Soetomo General Hospital
name: Menul Ayu Umborowati, Specialist
role: STUDY_CHAIR
References: