Trial | NCT03594877  Report issue

Title

Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients
Effectiveness of the Sublimated Mare Milk on the Gut Microbiome in Psoriasis and Healthy Patients

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
This study evaluates the effect of dietary supplement consisting of sublimated mare milk on intestinal microbiota among psoriasis and healthy participants.
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.
Study Started
Apr 01
2018
Primary Completion
Nov 30
2019
Study Completion
Dec 30
2020
Last Update
Feb 08
2021

Dietary Supplement Sublimated mare milk

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.

Psoriasis patients Experimental

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.

Healthy volunteers No Intervention

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.

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
No Results Posted