NCT03594877

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

June 25, 2018

Last Update Submit

February 3, 2021

Conditions

Psoriasis

Keywords

mare milkgut microbiomepsoriasisimmune markers

Outcome Measures

Primary Outcomes (2)

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

    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.

    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 Outcomes (2)

  • PASI index for psoriasis

    Baseline & 12 weeks

  • Change from baseline in Vitamin D levels

    Baseline & 12 weeks

Study Arms (2)

Psoriasis patients

EXPERIMENTAL

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

Healthy volunteers

NO INTERVENTION

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.

Interventions

Sublimated mare milkDIETARY_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.

Psoriasis patients

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Patients with no diagnosis of psoriasis
  • Aged 30 to 45 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center, Kazakhstan

Astana, 010000, Kazakhstan

Location

Related Publications (9)

  • Fung I, Garrett JP, Shahane A, Kwan M. Do bugs control our fate? The influence of the microbiome on autoimmunity. Curr Allergy Asthma Rep. 2012 Dec;12(6):511-9. doi: 10.1007/s11882-012-0291-2.

    PMID: 22886439BACKGROUND

  • Ely PH. Is psoriasis a bowel disease? Successful treatment with bile acids and bioflavonoids suggests it is. Clin Dermatol. 2018 May-Jun;36(3):376-389. doi: 10.1016/j.clindermatol.2018.03.011. Epub 2018 Mar 28.

    PMID: 29908580BACKGROUND

  • Yan D, Issa N, Afifi L, Jeon C, Chang HW, Liao W. The Role of the Skin and Gut Microbiome in Psoriatic Disease. Curr Dermatol Rep. 2017 Jun;6(2):94-103. doi: 10.1007/s13671-017-0178-5. Epub 2017 Apr 22.

    PMID: 28804689BACKGROUND

  • Scher JU, Ubeda C, Artacho A, Attur M, Isaac S, Reddy SM, Marmon S, Neimann A, Brusca S, Patel T, Manasson J, Pamer EG, Littman DR, Abramson SB. Decreased bacterial diversity characterizes the altered gut microbiota in patients with psoriatic arthritis, resembling dysbiosis in inflammatory bowel disease. Arthritis Rheumatol. 2015 Jan;67(1):128-39. doi: 10.1002/art.38892.

    PMID: 25319745BACKGROUND

  • Gao Z, Tseng CH, Strober BE, Pei Z, Blaser MJ. Substantial alterations of the cutaneous bacterial biota in psoriatic lesions. PLoS One. 2008 Jul 23;3(7):e2719. doi: 10.1371/journal.pone.0002719.

    PMID: 18648509BACKGROUND

  • Codoner FM, Ramirez-Bosca A, Climent E, Carrion-Gutierrez M, Guerrero M, Perez-Orquin JM, Horga de la Parte J, Genoves S, Ramon D, Navarro-Lopez V, Chenoll E. Gut microbial composition in patients with psoriasis. Sci Rep. 2018 Feb 28;8(1):3812. doi: 10.1038/s41598-018-22125-y.

    PMID: 29491401BACKGROUND

  • Eppinga H, Sperna Weiland CJ, Thio HB, van der Woude CJ, Nijsten TE, Peppelenbosch MP, Konstantinov SR. Similar Depletion of Protective Faecalibacterium prausnitzii in Psoriasis and Inflammatory Bowel Disease, but not in Hidradenitis Suppurativa. J Crohns Colitis. 2016 Sep;10(9):1067-75. doi: 10.1093/ecco-jcc/jjw070. Epub 2016 Mar 12.

    PMID: 26971052BACKGROUND

  • Yegorov S, Babenko D, Kozhakhmetov S, Akhmaltdinova L, Kadyrova I, Nurgozhina A, Nurgaziyev M, Good SV, Hortelano GH, Yermekbayeva B, Kushugulova A. Psoriasis Is Associated With Elevated Gut IL-1alpha and Intestinal Microbiome Alterations. Front Immunol. 2020 Oct 1;11:571319. doi: 10.3389/fimmu.2020.571319. eCollection 2020.

    PMID: 33117362RESULT

  • Togzhan Algazina, Alexandr Gulyayev, Alma Aimoldina, Almagul Kushugulova, Bakytgul Yermekbayeva*. Clinical assessment of the use of sublimated mare's milk in complex therapy of mild and moderate psoriasis // Journal of Global Pharma Technology.- 2020.- Vol.12.- Issue 06.- P. 18-25

    RESULT

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 20, 2018

Study Start

April 1, 2018

Primary Completion

November 30, 2019

Study Completion

December 30, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

KA(1)