Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

Sponsor

Dr. Soetomo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05254249

Collaborator

Universitas Airlangga (Other)

Enrollment

Location

Arms

7.8

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: Lactobacillus Plantarum IS-10506 Other: Placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Investigator)

Masking Description:

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

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 7, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Alpha and beta [12 weeks]
Alpha and beta diversity in gut microbiota profiles
Serum levels [12 weeks]
Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method
PASI scores [12 weeks]
Changes in PASI scores after the intervention

Secondary Outcome Measures

DLQI [12 weeks]
Changes in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patient Group Inclusion Criteria:

Psoriasis vulgaris patients with or without treatment
Mild to moderate degree
Age 18-70 years old
Willing to give informed consent

Healthy Control Group Inclusion Criteria:

Undiagnosed as Psoriasis
Body mass index (BMI) is matched with the patient group
Age 18-70 years old
Willing to give Informed Consent

Exclusion Criteria:

Patient Group Exclusion Criteria:

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

Healthy Control Group Exclusion Criteria:

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