Efficacy of Fecal Microbiota Transplantation in Critically Ill ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance: a Single-center, Non-blind, Exploratory Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Percentage of the effective improvement of enteral nutrition intolerance
研究概览
简要总结
Considering that intestinal microbiota plays a crucial role in intestinal function, fecal microbiota transplantation (FMT) may provide a new therapeutic strategy for the treatment of intestinal nutrition intolerance in critically ill ICU patients. The purpose of this study was to investigate the effects of FMT on the recovery of gastrointestinal dysfunction-induced enteral nutrition intolerance in critically ill patients admitted to ICU, and observe the effects on gastrointestinal barrier function, as well as the effects on length of stay in ICU, ICU mortality, in-hospital mortality, and 28-day mortality.
详细描述
Patients in the intensive care unit (ICU) are often at risk for gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction is associated with poorer clinical outcomes, including longer mechanical ventilation, longer ICU stay, and increased 90-day mortality. Due to the influence of primary severe diseases and the use of proton pump inhibitors (PPI) and antibiotics, ICU patients with severe illness may have severe disturbance of intestinal flora, impairment of intestinal barrier function, high incidence of gastrointestinal dysfunction-induced enteral nutrition intolerance, and severe intestinal systemic inflammation and organ function injury. Considering that intestinal microbiota plays a crucial role in intestinal function, fecal microbiota transplantation (FMT) may provide a new therapeutic strategy for the treatment of gastrointestinal dysfunction-induced enteral nutrition intolerance in critically ill ICU patients. The project plans through nasal jejunal tube way to give FMT, to investigate its effect on the recovery of gastrointestinal dysfunction-induced enteral nutrition intolerance in severe patients admitted to ICU, and to observe its effect on gastrointestinal barrier function.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 ≤ age ≤ 70 years old, any nationality, any gender;
- •Female patients have no potential fertility (i.e., no physical ability to conceive, including women who have been menopausal for 2 years) or no pregnancy plan;
- •Patients who have been in the ICU for at least 24 hours;
- •Patients with an expected ICU stay of at least 7 days;
- •Non-acute patients with at least one manifestation of gastrointestinal dysfunction leading to enteral nutrition intolerance;
- •Patients can cooperate or passively complete the relevant examination and complete the follow-up;
- •Informed consent is documented by means of a written, signed and dated informed consent form.
排除标准
- •Severe systemic infection, in early recovery period, hemodynamic instability or tissue hypoperfusion, severe imbalances in water and electrolyte status;
- •Patients who are considered by clinicians to be at high risk of death within 5 days, or who are subject to restricted treatment decisions;
- •Severe damage of intestinal barrier such as active massive bleeding and perforation of digestive tract;
- •Patients who cannot tolerate 50% of caloric calorie requirements with enteral nutrition due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons;
- •Nasal jejunal tube cannot be placed;
- •Planned or recent abdominal surgery (within 14 days);
- •Currently diagnosed with fulminant colitis or toxic megacolon;
- •Neutropenia (neutrophil count < 1500 /µL);
- •Patients with congenital or acquired immune deficiency;
- •Malignant hematologic diseases, such as lymphoma;
- •Autoimmune diseases;
- •Patients who have recently received high-risk immunosuppressive or cytotoxic drugs, such as rituximab, doxorubicin, or medium-high dose of steroid hormones (20mg/day or higher) for more than 4 weeks;
- •Pregnant or lactating women;
- •Participating in other clinical studies as a participant at the time of enrollment or within 3 months before inclusion;
- •Informed consent can not be obtained.
研究组 & 干预措施
Control group
Receive ICU standard treatment.
FMT intervention Group
In addition to ICU standard treatment, 50ml commercial intestinal bacterial suspension was administered via a naso-jejunal tube to the jejunum from 11:00 to 13:00 every day for 3 consecutive days.
干预措施: Fecal microbiota transplantation (FMT) by nasal jejunal tube (Biological)
结局指标
主要结局
Percentage of the effective improvement of enteral nutrition intolerance
时间窗: 24, 48, 72 and 96 hours after first FMT.
Change of intestinal nutrition intolerance.
次要结局
- 28-day mortality(28 days after inclusion.)
- Changes of intestinal microbiota and its metabolites(-48, 72 and 96 hours after first FMT.)
- Intestinal barrier function(-24, 0, 24, 48, 72 and 96 hours after first FMT.)
- Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score(-48, -24, 0, 24, 48, 72 and 96 hours after first FMT.)
- Peripheral blood cytokines and lymphocyte subsets(-24 and 72 hours after inclusion.)
- 90-day mortality(90 days after inclusion.)
- Intestinal barrier function(0, 24, 48, 72, 96, 120 hours after inclusion.)
- Acute gastrointestinal injury (AGI) score(0, 24, 48, 72, 96 and 120 hours after inclusion.)
- Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score(0, 24, 48, 72, 96, 120 hours after inclusion.)
- Usage of vasoactive drugs(0, 24, 48, 72, 96, 120 hours after inclusion.)
- C-reactive protein (CRP) and procalcitonin (PCT)(0, 24, 48, 72, 96, 120 hours after inclusion.)
- Peripheral blood cytokines and lymphocyte subsets(0 hour and 96 hours after inclusion.)
- ICU length of stay(From date of randomization until the date of discharge from the ICU or date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks)
- ICU mortality(From date of randomization until the date of discharge from the ICU or date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks)
- In-hospital mortality(From date of randomization until the date of discharge from the hospital or date of death from any cause during hospitalization, whichever came first, assessed up to 6 weeks)
- 28-day mortality(28 days after inclusion.)
- C-reactive protein (CRP)(-48, -24, 0, 24, 48, 72 and 96 hours after first FMT.)
研究者
Jiancheng Zhang
Prof. Jiancheng Zhang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology