NCT03657836

The Sublimated Mare Milk Supplement's Effect on Gut Mucosal Lining After Antibiotics

Evaluation of Effectiveness of the Sublimated Mare Milk Supplement in Protection of Gut Mucosal Lining During Antibiotic Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Nazarbayev University Medical Center · Academic / Other
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies the effect of sublimated mare milk supplement on gut microbiome of patients with acute bronchitis.

Detailed description

Food has a significant effect on the health of the body, the relationship between diet and health actualizes the importance of expanding the research of functional products. In mare's milk contains about 40 biological components necessary for the human body: amino acids, fats, enzymes (lysozyme, amylase), microelements (calcium, sodium, potassium, phosphorus, iron, magnesium, copper, iodine, sulfur, cobalt, zinc, bromine) and vitamins (A, C, B1, B2, B6, B12, E, H, PP, beta-carotene, folic acid) in optimally balanced proportions. 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

• Acute Bronchitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sublimated mare milk supplement	The dietary supplement consisting of sublimated mare milk packed in single-dose sachet.
DRUG	Standard antibiotic therapy	Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-01-20
• Completion: 2020-12-01
• First posted: 2018-09-05
• Last updated: 2021-02-08

Locations

1 site across 1 country: Kazakhstan