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Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05254249
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Dr. Soetomo General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Menul Ayu Umborowati, Specialist
Principal Investigator Affiliation Dr. Soetomo General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Indonesia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis Vulgaris
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Treatment Group

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.

Placebo Comparator: Placebo Group

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

No Intervention: Healty Control Group

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

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

Contact a Trial Team

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International Sites

Universitas Airlangga, Surabaya, Jawa Timur, Indonesia

Status

Recruiting

Address

Universitas Airlangga

Surabaya, Jawa Timur,

Site Contact

Menul Ayu Umborowati

menulayu@gmail.com

+628132885950

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