Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris
NCT05254249 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2022-02-24
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.
Conditions
- Psoriasis Vulgaris
Interventions
- 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
Sponsors & Collaborators
-
Universitas Airlangga
collaborator OTHER -
Dr. Soetomo General Hospital
lead OTHER_GOV
Principal Investigators
-
Menul Ayu Umborowati, Specialist · Dr. Soetomo General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-02-07
- Primary Completion
- 2022-08-31
- Completion
- 2022-10-31
Countries
- Indonesia
Study Locations
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