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

Nazarbayev University Medical Center

Status: Completed

Conditions: Psoriasis

Treatments: Dietary Supplement: Sublimated mare milk

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03594877

PsS.2017.1.1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Psoriasis patients

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Sublimated mare milk

Healthy volunteers

No Intervention group

Description:

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.