Evaluation of Effectiveness of the Sublimated Mare Milk Supplement in Protection of Gut Mucosal Lining During Antibiotic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in intestinal microbial composition
研究概览
简要总结
This clinical trial studies the effect of sublimated mare milk supplement on gut microbiome of patients with acute bronchitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged 4-5 years
- •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
排除标准
- •Severe forms of acute infections
- •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
研究组 & 干预措施
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.
干预措施: Sublimated mare milk supplement (Dietary Supplement)
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.
干预措施: Standard antibiotic therapy (Drug)
Antibiotics only
Participants will take the prescribed antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days.
干预措施: Standard antibiotic therapy (Drug)
结局指标
主要结局
Changes in intestinal microbial composition
时间窗: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 10, Day 15, Day 20, Day 25, Day 30, Day 35, Day 40, Day 45, Day 50, Day 55, Day 60
Rectal swabs will be taken for further analysis of DNA sequence with MiSeq Reporter PCR Amplicon.
Changes in intestinal immune status biomarkers.
时间窗: Baseline, Day 60
Levels of immune markers (cytokines, secretory Immunoglobulin A, interleukins) will be assessed from stool samples.
次要结局
- Changes in consistency of stool(Baseline, Day 60)
- Changes in color of stool,(Baseline, Day 60)
- Changes in weight of the patient(Baseline, Day 60)
- Defecation frequency(Baseline, up to 60 days)
研究者
Almagul Kushugulova
Head of the Laboratory of Human Microbiome and Longevity
Nazarbayev University Medical Center