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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Lactobacillus Plantarum IS-10506; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Menul Ayu Umborowati, Specialist; Phone Number: +6281328859509; Email: menulayu@gmail.com

Study Locations

• Indonesia
  • Jawa Timur
    • Surabaya, Jawa Timur, Indonesia
      • Recruiting
      • Universitas Airlangga
      • Contact: Menul Ayu Umborowati; Phone Number: +628132885950; Email: menulayu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group; 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.	Drug: Lactobacillus Plantarum IS-10506; Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU; Other Names: Probiotic
Placebo Comparator: Placebo Group; In the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks.	Other: Placebo; Placebo is an empty drug, given in capsule form with a dose of 2x1 sachets
No Intervention: Healty Control Group; Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dr. Soetomo General Hospital
• Collaborators: Universitas Airlangga
• Investigators: Study Chair: Menul Ayu Umborowati, Specialist, Dr. Soetomo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Psoriasis Vulgaris; Gut Microbiota; Foxp3; Interleukin-10; Psoriasis Area and Severity Index; Interleukin-17; Tumor Necrosis Factor- A; Lactobacillus Plantarum IS-10506
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 0315/KEPK/XI/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No