Study of human microbiome and probiotic supplementation under extreme environmental conditions.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Homeostasis of gut and oral microbiota ascertained through sequencing analysis
研究概览
简要总结
The trial on probiotic health supplement is to evaluate its efficacy in maintaining homeostasis of gut and oral microbiota in hypobaric hypoxia and cold conditions prevalent in high altitude areas. Considering the burgeoning literature on effect of gut and oral microbiota on immunity and metabolism in human body, the study will also evaluate the effect of the supplementation of the probiotic on these related parameters.
Study Design: Randomized double blind longitudinal interventional study will be conducted. The study will comprise of Placebo and Probiotic intervention group and will be conducted in the high altitude conditions of Ladakh. Baseline data will be acquired prior to administration of FSSAI approved probiotic supplement and follow up data will be acquired at intervals of 01 month for a total duration of 06 months.
Study parameters:
Microbial Profiling: DNA sequencing for microbial composition from stool and saliva samples
General Physiology viz., Blood Pressure, BMI, HRV
Biochemical Parameters: Lipid, Glucose, Vitamin, Stress Hormone profile from blood samples.
Immunological Parameters: Cytokine, Chemokine, Immunoglobulin and complement factor profiling
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •BMI: 18-27 No antibiotic treatment in last 3 months No history of gastro-intestinal disease Maintenance of oral hygiene.
排除标准
- •Subjects with pre-existing clinically identified digestive and GI tract disease including Chrones.
- •History of Bariatric surgery or intestinal injury.
结局指标
主要结局
Homeostasis of gut and oral microbiota ascertained through sequencing analysis
时间窗: Baseline at o months and monthly follow up for 06 months
次要结局
- Effect on physiological and biochemical parameters that are reported previously to be influenced by gut microbiota in scientific literature. Viz., Immunological: Cytokine, Chemokine, Immunoglobulin and complement factor profiling, Metabolic: Glucose, Hb1 Ac, Cortisol, Lipid Profile, Vitamin Profile.(Same as primary outcome)