University Medical Center, Kazakhstan
Astana, 010000, Kazakhstan
NCT Number: NCT03594877
This study evaluates the effect of dietary supplement consisting of sublimated mare milk on intestinal microbiota among psoriasis and healthy participants.
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Notify Me30 year–45 year
All sexes
Interventional
Not applicable
Astana, 010000, Kazakhstan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
.
Inclusion criteria
for experimental group:
Inclusion criteria
for healthy volunteers group.
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline & 12 weeks
Dermatological status of PASI index will be evaluated according to the international protocols for treatment of psoriasis (NICE guidance).
Time frame: Baseline & 12 weeks
Blood levels of Vitamin D will be compared between baseline and later periods in psoriasis patients.
Nazarbayev University Medical Center
Other
Effectiveness of the Sublimated Mare Milk on the Gut Microbiome in Psoriasis and Healthy Patients
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