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

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ClinicalTrials.gov Identifier: NCT03594877
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Eurasia Invest Ltd., Kazakhstan
Ministry of education and science Republic of Kazakhstan
Centre for Dermatology and Sexually Transmitted Diseases, Astana, Kazakhstan
Information provided by (Responsible Party):
Bakytgul Yermekbayeva, 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.

Condition or disease Intervention/treatment Phase
Psoriasis Dietary Supplement: Sublimated mare milk Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of the Sublimated Mare Milk on the Gut Microbiome in Psoriasis and Healthy Patients
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psoriasis patients
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.
Dietary Supplement: Sublimated 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.

No Intervention: Healthy volunteers
Healthy patients will be enrolled in this study, and their gut microbiota composition as well as immune system indicators will be used for comparison with the psoriasis group.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594877


Contacts
Contact: Bakytgul Yermekbayeva, MD, PhD +77017266283 bakytgul@yahoo.com
Contact: Madina Razbekova, MPH +77021457017 mrazbekova@nu.edu.kz

Locations
Kazakhstan
Nazarbayev University Medical Center Recruiting
Astana, Kazakhstan, 010000
Contact: Bakytgul Yermekbayeva, MD, PhD    +77017266283    bakytgul@yahoo.com   
Contact: Madina Razbekova, MPH    +77021457017    mrazbekova@nu.edu.kz   
Principal Investigator: Bakytgul Yermekbayeva, MD, PhD         
Sub-Investigator: Almagul Kushugulova, MD, PhD         
Sub-Investigator: Gulnar Batpenova, MD, PhD         
Sponsors and Collaborators
Nazarbayev University Medical Center
Eurasia Invest Ltd., Kazakhstan
Ministry of education and science Republic of Kazakhstan
Centre for Dermatology and Sexually Transmitted Diseases, Astana, Kazakhstan

Publications:

Responsible Party: Bakytgul Yermekbayeva, MD, PhD, Nazarbayev University Medical Center
ClinicalTrials.gov Identifier: NCT03594877     History of Changes
Other Study ID Numbers: PsS.2017.1.1
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bakytgul Yermekbayeva, Nazarbayev University Medical Center:
mare milk
gut microbiome
psoriasis
immune markers

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases