Effects of Dietary Fiber Enteral Nutrition on Bone Metabolism in Septic Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- The changes of bone metabolic markers PINP
研究概览
简要总结
Clinical and animal studies have found that sepsis can lead to a serious imbalance in the gut microecology, a reduction in probiotics, a reduction in short-chain fatty acid, a reduction in bone mass, and an increase in bone destruction, maintaining the stability of microecology can be one of the effective means of bone protection. But at present, the treatment of sepsis with early supplementation of probiotics is still controversial, and dietary fiber intake has significantly changed the composition of the microbiota, it may be a safe and effective method to prevent bone loss in sepsis. Further study on it will provide reliable theoretical basis and intervention target for early, safe and effective prevention of osteoporosis.
详细描述
In recent years, researchers have found that the incidence of bone loss in ICU patients is significantly higher than that in the control group of the same age, patients with sepsis whose bone balance is disrupted by higher overresorption, bone destruction and release of multiple active cytokines and toxins become the"Invisible killer"of the ICU, however, the pathogenesis of osteoporosis is not clear, and the existing drugs for osteoporosis can not be safely used in critically ill patients. The gastrointestinal tract is the"Initiating organ"and"Central organ" of multiple organ dysfunction and forms a complex and powerful"Gut-bone axis"with bone, which plays a key role in bone metabolism, but the mechanism is unclear. The human gut contains a dense and diverse microbial community, which plays an important role in nutrition, metabolism and immunity, small intestinal microecology can affect bone turnover through a variety of pathways, especially the metabolite short-chain fatty acid FAS (SCFAs) , which can inhibit osteoclast activity by regulating inflammatory cytokines and immune cells, promote the formation of osteoblasts and other aspects to maintain the stability of bone metabolism, and then protect the health of bones, forming a"Gut-microcology-bone"axis.
Clinical and animal studies have found that sepsis can lead to a serious imbalance in the gut microecology, a reduction in probiotics, a reduction in short-chain fatty acid, a reduction in bone mass, and an increase in bone destruction, maintaining the stability of microecology can be one of the effective means of bone protection. But at present, the treatment of sepsis with early supplementation of probiotics is still controversial, and dietary fiber intake has significantly changed the composition of the microbiota, it may be a safe and effective method to prevent bone loss in sepsis. Further study on it will provide reliable theoretical basis and intervention target for early, safe and effective prevention of osteoporosis. Therefore, based on the above research background, Investigators intend to evaluate the overall safety and efficacy of dietary fiber-containing enteral nutrition supplementation in patients with sepsis by observing changes in bone metabolism-related indicators, to provide the basis for further basic and mechanism research
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily cooperated with the study and signed the informed consent form, and could be followed up
- •It meets the diagnostic criteria of Sepsis 2016 Sepsis 3.0 guidelines
- •After treatment, the Hemodynamics is stable and the patient is ready to start enteral nutrition support
- •Those who need tube feeding for more than 14 days because of the need of illness and can not take food by mouth
排除标准
- •People who have had osteoporosis in the past
- •Admission due to fracture
- •The shock was not corrected, and the patients were maintained with a large amount of vaso-active drugs (0.5 ug/kg/min of noradrenaline) , but could not be given enteral nutrition
- •Supplement with probiotics or prebiotics alone
- •Parturients
- •No written informed consent
结局指标
主要结局
The changes of bone metabolic markers PINP
时间窗: 28 day
The changes of bone metabolic markers β-CTX
时间窗: 28 day
The venous blood was drawn daily before and after the enrollment (the first, third, seventh and fourteenth days) ，and β- CTX for comparison
次要结局
- Changes in intestinal flora(28 day)
- Length of Apache II score(28 day)
- The change of systemic inflammatory response index: the value of IL-6 in systemic inflammatory response(28 day)
- Abdominal symptoms (abdominal distention)(28 day)
- The change of systemic inflammatory response index: the value of TNF-α in systemic inflammatory response(28 day)
- Changes in short-chain fatty acid of metabolites(28 day)
- Abdominal symptoms ( diarrhea incidence)(28 day)
- The change of systemic inflammatory response index: the value of Procalcitonin in systemic inflammatory response(28 day)
- Length of ICU stay(28 day)
研究者
Cuiping Liu
Chief researcher
Zhujiang Hospital