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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03594877

Enrollment

Registered

2018-07-20

Start date

2018-04-01

Completion date

2020-12-30

Last updated

2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

mare milk, gut microbiome, psoriasis, immune markers

Brief summary

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

Detailed 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.

Interventions

DIETARY_SUPPLEMENTSublimated 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in composition of microorganisms in stool after the supplement intervention.	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.	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.

Secondary

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

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026