Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients

Study Overview
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Brief Summary
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This study evaluates the effect of dietary supplement consisting of sublimated mare milk on intestinal microbiota among psoriasis and healthy participants.

Detailed Description
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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.

Official Title
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Effectiveness of the Sublimated Mare Milk on the Gut Microbiome in Psoriasis and Healthy Patients

Conditions
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Psoriasis

Intervention / Treatment
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* Dietary Supplement: Sublimated mare milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psoriasis patients<br>Patients with verified diagnosis of psoriasis would be given standard treatment for the first 3 months, and then followed with the standard therapy accompanied with the sublimated mare milk supplement for additional 3 months. | Dietary Supplement: Sublimated mare milk<br>* The dietary supplement mare milk product, which is obtained from fresh (few hours) through sublimation process. This product is first mixed with warm water (37-38 degrees of Celsius) and then will be given to participants.<br>|
| No Intervention: Healthy volunteers<br>Healthy patients will be enrolled in this study, and their gut microbiota composition as well as immune system indicators will be used for comparison with the psoriasis group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in composition of microorganisms in stool after the supplement intervention. | Change in composition of intestinal microbiota will be determined comparing with the baseline results using DNA sequencing Illumina MiSeq System. | Baseline, 6 weeks, 12 weeks | 
| Change from baseline of biomarkers of inflammation in intestines. | 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. | Baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI index for psoriasis | Dermatological status of PASI index will be evaluated according to the international protocols for treatment of psoriasis (NICE guidance). | Baseline & 12 weeks | 
| Change from baseline in Vitamin D levels | Blood levels of Vitamin D will be compared between baseline and later periods in psoriasis patients. | Baseline & 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mare milk, gut microbiome, psoriasis, immune markers