Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients
NCT ID: NCT03594877
Last Updated: 2021-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-04-01
2020-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
45 Years
ALL
Yes
Sponsors
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Eurasia Invest Ltd.
INDUSTRY
Ministry of Education and Science, Republic of Kazakhstan
OTHER_GOV
Centre for Dermatology and Sexually Transmitted Diseases, Astana, Kazakhstan
UNKNOWN
Nazarbayev University Medical Center
OTHER
Responsible Party
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Bakytgul Yermekbayeva
MD, PhD
Locations
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University Medical Center, Kazakhstan
Astana, , Kazakhstan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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
Other Identifiers
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PsS.2017.1.1
Identifier Type: -
Identifier Source: org_study_id
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