Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

NCT05254249 | Unknown Phase 1

• 1 other identifier: 0315/KEPK/XI/2021
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Psoriasis Vulgaris; Psoriasis Area and Severity Index; Interleukin-17; Tumor Necrosis Factor- A; Interleukin-10; Foxp3; Lactobacillus Plantarum IS-10506; Gut Microbiota

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• DLQI

  12 weeks

Study Arms (3)

Treatment Group

ACTIVE COMPARATOR

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

Placebo Group

PLACEBO COMPARATOR

In the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks.

Other: Placebo

Healty Control Group

NO INTERVENTION

Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile.

Interventions

Lactobacillus Plantarum IS-10506 DRUG

Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU

Also known as: Probiotic

Treatment Group

Placebo OTHER

Placebo is an empty drug, given in capsule form with a dose of 2x1 sachets

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psoriasis vulgaris patients with or without treatment
• Mild to moderate degree
• Age 18-70 years old
• Willing to give informed consent
• Undiagnosed as Psoriasis
• Body mass index (BMI) is matched with the patient group
• Age 18-70 years old
• Willing to give Informed Consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead
• Universitas Airlangga: collaborator

Study Sites (1)

Universitas Airlangga

Surabaya, East Java, Indonesia

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Menul Ayu Umborowati, Specialist

  Dr. Soetomo General Hospital

  STUDY CHAIR

Central Study Contacts

Menul Ayu Umborowati, Specialist

CONTACT

+6281328859509; menulayu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Probiotic and placebo packaging are made the same, and drug code is randomized by pharmacy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor, dermatovenereologist

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

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: February 7, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

ID (1)