Effectiveness of the Sublimated Mare Milk on the Gut Microbiome in Psoriasis and Healthy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in composition of microorganisms in stool after the supplement intervention.
研究概览
简要总结
This study evaluates the effect of dietary supplement consisting of sublimated mare milk on intestinal microbiota among psoriasis and healthy participants.
详细描述
The gut microbiome is believed to play an important role in the immune system regulation, since intestines are the largest lymphoid organ in a human body. Deviations from healthy composition of intestinal flora are associated with various diseases including allergy and autoimmunity. Psoriasis is the one of the long-lasting autoimmune diseases that is characterized by patches on the skin and further health complications throughout the life. However, lack of studies does not allow proper evaluation of role of gut microbiome in psoriasis patients. Therefore, potential interplay between gut microbiome and immune system in psoriasis would be studied in this clinical trial. Particularly, the investigators hypothesize that sublimated mare milk supplement can have an impact on gut immune system and gut microbiome composition in the psoriasis patients.
In this trial, there will be two parallel groups: crossover psoriasis patients (standard treatment first for 3 months, next 3 months standard treatment plus sublimated mare milk supplement) and healthy volunteers group. Subsequently, association of intestinal flora with immune status will be analyzed and compared between these groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for experimental group:
- •Patients with a verified diagnosis of moderate to severe psoriasis
- •Aged 30 to 45 years
- •Absence of an allergic reaction to dairy products
- •Lack of prescription of antibacterial drugs for the last 3 months prior to admission
- •Willingness to consent to participate in the study
- •Inclusion criteria for healthy volunteers group.
- •Patients with no diagnosis of psoriasis
- •Aged 30 to 45 years
排除标准
- •Presence of chronic dermatoses, diseases of the organs of the gastrointestinal tract
- •Presence of severe concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, oncological, mental health and decompensated endocrine diseases, tuberculosis, and HIV infection
- •Pregnancy and/or lactation
- •Patient involvement in other clinical trials within the last 3 months
- •Refusal to participate in the study
结局指标
主要结局
Change from baseline in composition of microorganisms in stool after the supplement intervention.
时间窗: Baseline, 6 weeks, 12 weeks
Change in composition of intestinal microbiota will be determined comparing with the baseline results using DNA sequencing Illumina MiSeq System.
Change from baseline of biomarkers of inflammation in intestines.
时间窗: Baseline, 6 weeks, 12 weeks
The change of immunity will be evaluated from stool specimens according to baseline results of inflammatory cytokines, interleukins, and antibodies. Number of patients, in whom change is statistically significant, will be reported in the results.
次要结局
- Change from baseline in Vitamin D levels(Baseline & 12 weeks)
- PASI index for psoriasis(Baseline & 12 weeks)
研究者
Bakytgul Yermekbayeva
MD, PhD
Nazarbayev University Medical Center