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Completed

NCT Number: NCT03594877

Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients

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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Key information

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center, Kazakhstan

Astana, 010000, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublimated mare milk

Dietary Supplement

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.

Primary outcomes

  1. Change from baseline in composition of microorganisms in stool after the supplement intervention.

    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.

  2. Change from baseline of biomarkers of inflammation in intestines.

    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.

Secondary outcomes

  1. PASI index for psoriasis

    Time frame: Baseline & 12 weeks

    Dermatological status of PASI index will be evaluated according to the international protocols for treatment of psoriasis (NICE guidance).

  2. Change from baseline in Vitamin D levels

    Time frame: Baseline & 12 weeks

    Blood levels of Vitamin D will be compared between baseline and later periods in psoriasis patients.

Sponsors and collaborators

Lead sponsor

Nazarbayev University Medical Center

Other

Collaborators

  • Centre for Dermatology and Sexually Transmitted Diseases, Astana, Kazakhstan
  • Eurasia Invest Ltd.
  • Ministry of Education and Science, Republic of Kazakhstan

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 20, 2018
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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