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

February 3, 2021 updated by: Bakytgul Yermekbayeva, Nazarbayev University Medical Center

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

This study evaluates the effect of dietary supplement consisting of sublimated mare milk on intestinal microbiota among psoriasis and healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • University Medical Center, Kazakhstan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline & 12 weeks
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.
Baseline & 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nazarbayev University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PsS.2017.1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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