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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594877
• Other study ID #: PsS.2017.1.1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Nazarbayev University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
Kazakhstan	University Medical Center, Kazakhstan	Astana

Sponsors (4)

Lead Sponsor	Collaborator
Nazarbayev University Medical Center	Centre for Dermatology and Sexually Transmitted Diseases, Astana, Kazakhstan, Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (9)

Codoñer FM, Ramírez-Bosca A, Climent E, Carrión-Gutierrez M, Guerrero M, Pérez-Orquín JM, Horga de la Parte J, Genovés S, Ramón D, Navarro-López 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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.- Vo

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. — View Citation

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-1a and Intestinal Microbiome Alterations. Front Immunol. 2020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PASI index for psoriasis	Dermatological status of PASI index will be evaluated according to the international protocols for treatment of psoriasis (NICE guidance).	Baseline & 12 weeks
Secondary	Change from baseline in Vitamin D levels	Blood levels of Vitamin D will be compared between baseline and later periods in psoriasis patients.	Baseline & 12 weeks