Clinical trial NCT03594877: Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients
Official title: Effectiveness of the Sublimated Mare Milk on the Gut Microbiome in Psoriasis and Healthy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: mare milk
gut microbiome
psoriasis
immune markers
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
Collaborators: name: Eurasia Invest Ltd.
name: Ministry of Education and Science, Republic of Kazakhstan
name: Centre for Dermatology and Sexually Transmitted Diseases, Astana, Kazakhstan
First posted: 2018-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in composition of microorganisms in stool after the supplement intervention.
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline of biomarkers of inflammation in intestines.
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: PASI index for psoriasis
timeFrame: Baseline & 12 weeks
measure: Change from baseline in Vitamin D levels
timeFrame: Baseline & 12 weeks
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: University Medical Center, Kazakhstan
Study officials:
References:
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