Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Soetomo General Hospital
• Collaborator: Universitas Airlangga

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