Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594877
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : February 8, 2021
Sponsor:
Collaborators:
Eurasia Invest Ltd.
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

Tracking Information
First Submitted Date  ICMJE June 25, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE April 1, 2018
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients
Official Title  ICMJE Effectiveness of the Sublimated Mare Milk on the Gut Microbiome in Psoriasis and Healthy Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Sublimated mare milk
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2020
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03594877
Other Study ID Numbers  ICMJE PsS.2017.1.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bakytgul Yermekbayeva, Nazarbayev University Medical Center
Study Sponsor  ICMJE Nazarbayev University Medical Center
Collaborators  ICMJE
  • Eurasia Invest Ltd.
  • Ministry of Education and Science, Republic of Kazakhstan
  • Centre for Dermatology and Sexually Transmitted Diseases, Astana, Kazakhstan
Investigators  ICMJE Not Provided
PRS Account Nazarbayev University Medical Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP