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Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status
Recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Lactobacillus Plantarum IS-10506
Placebo
Sponsored by
Dr. Soetomo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis Vulgaris, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor- A, Interleukin-10, Foxp3, Lactobacillus Plantarum IS-10506, Gut Microbiota

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitas AirlanggaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Treatment Group

Placebo Group

Healty Control Group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2022
Last Updated
February 15, 2022
Sponsor
Dr. Soetomo General Hospital
Collaborators
Universitas Airlangga
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1. Study Identification

Unique Protocol Identification Number
NCT05254249
Brief Title
Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Soetomo General Hospital
Collaborators
Universitas Airlangga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A double blinded randomized clinical trial using a prospective cohort method in psoriasis vulgaris patients with purposive sampling.
Masking
ParticipantInvestigator
Masking Description
Probiotic and placebo packaging are made the same, and drug code is randomized by pharmacy
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
In the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks.
Arm Title
Healty Control Group
Arm Type
No Intervention
Arm Description
Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile.
Intervention Type
Drug
Intervention Name(s)
Lactobacillus Plantarum IS-10506
Other Intervention Name(s)
Probiotic
Intervention Description
Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo is an empty drug, given in capsule form with a dose of 2x1 sachets
Primary Outcome Measure Information:
Title
Alpha and beta
Description
Alpha and beta diversity in gut microbiota profiles
Time Frame
12 weeks
Title
Serum levels
Description
Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method
Time Frame
12 weeks
Title
PASI scores
Description
Changes in PASI scores after the intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
DLQI
Description
Changes in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Menul Ayu Umborowati, Specialist
Phone
+6281328859509
Email
menulayu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menul Ayu Umborowati, Specialist
Organizational Affiliation
Dr. Soetomo General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Universitas Airlangga
City
Surabaya
State/Province
Jawa Timur
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Menul Ayu Umborowati
Phone
+628132885950
Email
menulayu@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

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