USE OF NON-INVASIVE BIOMARKERS TO ASSESS THE ROLE OF PROBIOTICS IN SLEEP REGULATION AND STRESS ATTENUATION IN SURGICAL PATIENTS- A RANDOMISED DOUBLE BLIND CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 1. To find out whether probiotics alter the impact of the gut microbiome on surgery related sleep and stress.
研究概览
简要总结
We have planned randomised double blind clinical trial which will explore the possibilty of a link between the gut microbiome , sleep and stress. We plan to alter the gut microbiome with a fast acting probiotic formulation containing lactobacillus and bifidobacterium species. in 160 patients aged between 16-65 years and posted for elective major surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Female/ male patients posted for elective major surgeries under central neuraxial block or general anaesthesia 2)Age between 20-65 years.
- •Having ability to read, hear, write and speak Kannada to answer the questionnaire.
排除标准
- •Patients on chemotherapy / radiotherapy 2)Patients with diseases of the gut/ GI symptoms/psychiatric symptoms 3)Patients with oral lesions 4)On oral antacids/ antidiabetics/antibiotics 5) Patients with history of gastric bypass surgery Those with moderate /severe pain.
结局指标
主要结局
1. To find out whether probiotics alter the impact of the gut microbiome on surgery related sleep and stress.
时间窗: 1. To find out whether probiotics alter the impact of the gut microbiome on surgery related sleep and stress on the 4 th day evening before the scheduled surgery between 8 to 9 pm.. | 2. To find out if the gut microbiome affects surgery related sleep and stress on 4 th day evening before surgery between 8 and 9 pm.
2. To find out if the gut microbiome affects surgery related sleep and stress
时间窗: 1. To find out whether probiotics alter the impact of the gut microbiome on surgery related sleep and stress on the 4 th day evening before the scheduled surgery between 8 to 9 pm.. | 2. To find out if the gut microbiome affects surgery related sleep and stress on 4 th day evening before surgery between 8 and 9 pm.
次要结局
- SECONDARY OBJECTIVES:(1. To find out whether probiotics alter the impact of the gut microbiome on surgery related sleep and stress.)