Metabonomics of Chronic Obstructive Pulmonary Disease and Fecal Microbial Transplantation in the Treatment of Malnutrition
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the changes of COPD
研究概览
简要总结
Oxidative stress can affect the balance of intestinal flora and intestinal structure of patients, resulting in intestinal flora disorder. Its bacterial metabolites stimulate the parasympathetic nerve, regulate insulin secretion and other metabolic pathways of patients through neuroendocrine regulation, resulting in abnormal energy metabolism of lipids and sugars in the digestive tract, and finally lead to malnutrition.We hypothesized that fecal bacteria transplantation could reconstruct the normal intestinal flora, restore the intestinal digestion and absorption function of chronic obstructive pulmonary disease（COPD）patients and improve the state of malnutrition.
详细描述
- improve the COPD patients with malnutrition is the key to improve the digestion and absorption function of chronic obstructive pulmonary disease (COPD) is one of the world's third most common cause of death, is characterized by progressive airflow limited, mainly by the long-term exposure to tobacco smoke and other harmful air pollutants.
It has been reported that 20%-71% of COPD patients suffer from malnutrition, and there is a negative correlation between BMI and prognosis.
There is increasing evidence that patients with COPD with lower BMI or fat-free mass index are associated with poorer prognosis and impaired long-term survival.
At present, nutrition supplements are mainly used to solve the problem of COPD malnutrition, including vitamins and minerals, essential amino acids and biological amino acids, anti-inflammatory omega-3, high fat and high carbohydrate, etc., while the causes of COPD malnutrition and the relationship between COPD and metabolism have not been paid attention to.
Although there is evidence that there is no malnutrition nutritional support can improve the prognosis of patients with COPD, but exist in patients with malnutrition, due to impaired digestion and absorption, increase nutrition supply, prone to patients with abdominal distension, vomiting, and diarrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD
- •Tobacco use: current or former smokers with a continuous smoking history of more than 1 year.
- •Subjects are willing and able to complete the follow-up according to the plan.
- •Subjects can cooperate to complete relevant examination items.
- •Compliance: Subjects must be willing to return to the hospital and complete all visits and evaluations according to the protocol.
排除标准
- •Having a significant disease or condition other than COPD that, in the Investigator's judgment, would put the subject at risk for participating in the study or affect the study outcome and the subject's ability to participate in the study.
- •Women who are pregnant or breastfeeding or who plan to become pregnant during the study period.
- •Digestive system: ① patients with known gastrointestinal organic diseases.
- •② Complicated with intestinal double infection, such as Clostridium difficile infection, EHEC, Salmonella, Shigella, Campylobacter, plague and cytomegalovirus;
- •③ patients with various acute infections, tumors, severe arrhythmias, mental disorders, drug or alcohol addiction; (4) pregnant or lactating women; (5) Use of antibiotics or probiotics within the last 4 weeks; (6) There are taboo witnesses for this study; (7) Clinical investigators who were conducting other related COPD studies at the time of enrollment or within 3 months before enrollment;
- •Complicated with serious primary diseases of heart, liver, kidney, hematopoietic system and other important organs or systems.
- •Patients with lower back, chest and abdomen injuries or after surgery.
- •People with mental disorder or cognitive impairment.
- •Non-compliance: Subjects did not follow the study procedures, including non-compliance to complete the journal.
- •Informed consent validity is in doubt: Subjects with a history of psychosis, mental retardation, poor motivation, substance abuse (including drugs and alcohol), or other medical conditions that limit the effectiveness of informed consent in this study.
- •Obesity (BMI≥28) Hyperlipidemia (1.5 times the upper limit of normal value of plasma total cholesterol > or 1.5 times the upper limit of normal value of triglyceride BBB>; Confirmed diabetic patients; Diagnosed cancer patients; Have used any antibiotics or antibiotics in the last 2 weeks.
结局指标
主要结局
the changes of COPD
时间窗: 6 months
The number of acute exacerbations in the previous year and the time of the last acute exacerbation
Nutritional indicators in COPD malnutrition subjects during the whole 6 months
时间窗: 6 months
including prealbumin, nutritional risk screening 2002 and scored patient-generated subjective global assessment.
Changes of intestinal flora in COPD malnutrition subjects during the whole 6 months
时间窗: 6 months
The changes of intestinal flora were detected by 16SrDNA technology during the 6 months.
次要结局
未报告次要终点