Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

NCT05254249 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-02-24

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254249 on ClinicalTrials.gov