Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254249
• Other study ID #: 0315/KEPK/XI/2021
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 7, 2022
• Est. completion date: October 2022

Study information

• Verified date: February 2022
• Source: Dr. Soetomo General Hospital
• Contact: Menul Ayu Umborowati, Specialist
• Phone: +6281328859509
• Email: menulayu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Lactobacillus Plantarum IS-10506
Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU

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

Locations

Country	Name	City	State
Indonesia	Universitas Airlangga	Surabaya	Jawa Timur

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Soetomo General Hospital	Universitas Airlangga

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alpha and beta	Alpha and beta diversity in gut microbiota profiles	12 weeks
Primary	Serum levels	Changes in serum levels of TNF-a, IL-17, IL-10, and Foxp3 by ELISA method	12 weeks
Primary	PASI scores	Changes in PASI scores after the intervention	12 weeks
Secondary	DLQI	Changes in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires	12 weeks