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临床试验/NCT05254249
NCT05254249Unknown1 期

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

Dr. Soetomo General Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年2月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
75
试验地点
1
主要终点
Alpha and beta

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Probiotic and placebo packaging are made the same, and drug code is randomized by pharmacy

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Lactobacillus Plantarum IS-10506 (Drug)

Placebo Group

Placebo Comparator

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

干预措施: Placebo (Other)

结局指标

主要结局

Alpha and beta

时间窗: 12 weeks

Alpha and beta diversity in gut microbiota profiles

PASI scores

时间窗: 12 weeks

Changes in PASI scores after the intervention

Serum levels

时间窗: 12 weeks

Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method

次要结局

  • DLQI(12 weeks)

研究者

发起方
Dr. Soetomo General Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Menul Ayu Umborowati, dr., Sp.KK

doctor, dermatovenereologist

Dr. Soetomo General Hospital

研究点 (1)

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