Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients
- Conditions
- Psoriasis
- Interventions
- Dietary Supplement: Sublimated mare milk
- Registration Number
- NCT03594877
- Lead Sponsor
- Nazarbayev University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psoriasis patients Sublimated mare milk 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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).
Trial Locations
- Locations (1)
University Medical Center, Kazakhstan
🇰🇿Astana, Kazakhstan