The Sublimated Mare Milk Supplement's Effect on Gut Mucosal Lining After Antibiotics
NCT ID: NCT03657836
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
12 participants
INTERVENTIONAL
2018-08-01
2020-12-01
Brief Summary
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Detailed Description
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A high percentage of nutrients, including vitamins, amino acids, contribute to immunomodulation, increasing the adaptogenic properties of the body. Valiev A demonstrated the effect of the essential fatty acids of mare's milk on immunocompetent cells and non-specific resistance after 6 weeks from the beginning of inclusion in the ration of mare's milk.
Secretory IgA is the main immunoglobulin of mare's milk. The homology of human secretory IgA and mare's was previously demonstrated by cross-reactions using human anti-IgA antiserum.
The mare's milk has a powerful detoxification effect, the mare's microflora neutralizes the effect of mutagens, possesses, replenishes with the necessary complex of nutrients and removes toxins from the body. The milk has a certain degree of antimicrobial effect in relation to opportunistic and pathogenic fungi, bacteria and viruses due to its own microflora.
The mare's milk is rich in active substances, natural enzymes that help regulate intestinal flora, limiting the growth of unwanted bacteria and increasing the growth of bifidobacteria and lactic acid bacteria.
In addition, the composition of mare's milk provided immunoglobulins A, M and G, which act as a marker of those microorganisms that can be pathogenic, which facilitates the protection task.
The high antimicrobial activity of mare's milk is associated with the lysozyme contained in it, immunoglobulins, lactoperoxidase and lactoferrin. Getting into the digestive tract lysozyme has a powerful normalizing effect on the composition of the microbial flora of the mouth and intestines. Lysozyme of breast milk is 100 times more active than lysozyme of cow's milk. It not only inhibits the growth of pathogenic flora, but also promotes the growth of bifidoflora in the intestines of infants.
In the framework of the project, methods for the restoration of the mucos layer of the intestine after antibiotic therapy will be developed. In order to develop the algorithm, preliminary studies will be made of changes in the structure of the intestinal microbiota after antibiotic therapy. Recruiting of patients with infectious / non-infectious pathology is supposed, clinical and laboratory examination, biomaterial sampling during antibiotic therapy, 1-5 days and 1-60 days after completion will be performed. Along with the study of microflora, local immunity studies will be carried out. To study the fundamental foundations, experimental studies will be carried out on laboratory animals. On the basis of the knowledge obtained, an algorithm for the restoration of the mucinous layer of the intestine after antibiotic therapy will be published in the form of methodological recommendations.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dietary supplement and antibiotics
Participants will take a supplement of 1 sachet (20 mg) dissolved in 200 ml of warm water (36-37 °C) once a day for 60 days accompanied with the standard antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days.
Sublimated mare milk supplement
The dietary supplement consisting of sublimated mare milk packed in single-dose sachet.
Standard antibiotic therapy
Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.
Antibiotics only
Participants will take the prescribed antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days.
Standard antibiotic therapy
Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.
Interventions
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Sublimated mare milk supplement
The dietary supplement consisting of sublimated mare milk packed in single-dose sachet.
Standard antibiotic therapy
Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.
Eligibility Criteria
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Inclusion Criteria
* The voluntary informed consent of the parent to participate in the study
* Established diagnosis of acute upper respiratory tract disease with prescription of antibacterial therapy
* The duration of symptoms of acute upper respiratory tract disease no more than 72 hours
* Lack of prescription of antibacterial drugs in the last 3 months
Exclusion Criteria
* The presence in the history of taking probiotics and antibiotics for three months before admission to hospital
* Presence in the anamnesis of chronic diseases of the digestive tract, and also of any surgeries on the digestive tract
* The presence of severe concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, cancer, mental and decompensated endocrine diseases, tuberculosis, HIV infection
* Patient involvement in other clinical trials within the last 3 months
* Lack of willingness of the patient to cooperate with the doctor-researcher
4 Years
5 Years
ALL
No
Sponsors
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Eurasia Invest Ltd.
INDUSTRY
Ministry of Education and Science, Republic of Kazakhstan
OTHER_GOV
Nazarbayev University Medical Center
OTHER
Responsible Party
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Almagul Kushugulova
Head of the Laboratory of Human Microbiome and Longevity
Principal Investigators
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Almagul Kushugulova, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Laboratory Astana
Locations
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University Medical Center
Astana, , Kazakhstan
Countries
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References
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Valiev AG. [Features of secondary immune response and status of nonspecific resistance of the rat, fed rations with mare's milk, rich in essential fatty acids]. Vopr Pitan. 2001;70(5):10-3. Russian.
Pahud JJ, Mach JP. Equine secretory IgA and secretory component. Int Arch Allergy Appl Immunol. 1972;42(2):175-86. doi: 10.1159/000230604. No abstract available.
Foekel C, Schubert R, Kaatz M, Schmidt I, Bauer A, Hipler UC, Vogelsang H, Rabe K, Jahreis G. Dietetic effects of oral intervention with mare's milk on the Severity Scoring of Atopic Dermatitis, on faecal microbiota and on immunological parameters in patients with atopic dermatitis. Int J Food Sci Nutr. 2009;60 Suppl 7:41-52. doi: 10.1080/09637480802249082. Epub 2009 May 21.
Wulijideligen, Asahina T, Hara K, Arakawa K, Nakano H, Miyamoto T. Production of bacteriocin by Leuconostoc mesenteroides 406 isolated from Mongolian fermented mare's milk, airag. Anim Sci J. 2012 Oct;83(10):704-11. doi: 10.1111/j.1740-0929.2012.01010.x. Epub 2012 Mar 13.
Hancock JT, Salisbury V, Ovejero-Boglione MC, Cherry R, Hoare C, Eisenthal R, Harrison R. Antimicrobial properties of milk: dependence on presence of xanthine oxidase and nitrite. Antimicrob Agents Chemother. 2002 Oct;46(10):3308-10. doi: 10.1128/AAC.46.10.3308-3310.2002.
Palmer AC. Nutritionally mediated programming of the developing immune system. Adv Nutr. 2011 Sep;2(5):377-95. doi: 10.3945/an.111.000570. Epub 2011 Sep 6.
ADIYAR NURGAZIYEV, YERMEK AITENOV et al. Effect of mare's milk prebiotic supplementation on the gut microbiome and the immune system following antibiotic therapy // B IOD I V E R S I T A S.- Volume 21, Number 11, November 2020 Pages: 5065-5071 DOI: 10.13057/biodiv/d211110
SAMAT KOZHAKHMETOV, DMITRIY BABENKO. The combination of mare's milk and grape polyphenol extract for treatment of dysbiosis induced by dextran sulfate sodium // B IOD I V E R S I T A S Volume 21, Number 5, May 2020 Pages: 2275-2280 DOI: 10.13057/biodiv/d210558
Almagul Kushugulova, Samat Kozhakhmetov. Mare's milk as a prospective functional product //Functional Foods in Health and Disease. = 2018; 8(11): 537-543
Other Identifiers
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AP05135073
Identifier Type: -
Identifier Source: org_study_id
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