Fecal Microbiota Transplantation for 90-Day Outcome of Clinical Use in ICU Sepsis: a Single-Center, Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- All-Cause Mortality at 90 Days
研究概览
简要总结
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, representing one of the leading causes of death in intensive care units (ICUs) worldwide. Gut microbiota disruption is increasingly recognized as a key driver of persistent inflammation and multiple organ dysfunction in septic patients. Fecal microbiota transplantation (FMT) has emerged as a promising approach to restore gut microbial homeostasis. This study hypothesizes that FMT acts not through long-term engraftment of donor microbes, but via a "functional pulse" - a potent, transient biological intervention that delivers high-dose microbial metabolites (e.g., short-chain fatty acids), competitively inhibits pathogens, and rapidly modulates intestinal immune cell functions.
This is a single-center, open-label, randomized controlled trial conducted in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. A total of 60 adult patients diagnosed with sepsis according to Sepsis-3 criteria within 24 hours of ICU admission will be randomized in a 1:1 ratio to receive either ICU standard care alone (control group) or ICU standard care plus FMT administered via a nasojejunal tube for three consecutive days (intervention group). The primary endpoint is all-cause mortality at 90 days. Secondary endpoints include ICU mortality, in-hospital mortality, 28-day mortality, changes in gut microbiota composition and metabolites, serum citrulline levels as a marker of intestinal barrier function, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, vasopressor requirements, C-reactive protein and procalcitonin levels, fluid balance, incidence of ICU delirium and feeding intolerance, and 90-day hospital readmission rate. Safety outcomes include gastrointestinal symptoms and transient fever.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years, any ethnicity, any gender.
- •Diagnosis of sepsis according to the Sepsis-3 criteria (infection with an acute change in SOFA score ≥ 2 points).
- •Signed written informed consent.
排除标准
- •Patients whom the attending clinician considers to have a high risk of death within 5 days, or patients with treatment limitations in place.
- •Active major gastrointestinal bleeding, perforation, or other severe impairment of the intestinal barrier.
- •Patients unable to tolerate enteral nutrition meeting ≥50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula.
- •Planned or recent abdominal surgery (within 14 days).
- •Current diagnosis of fulminant colitis or toxic megacolon.
- •Recent receipt of high-risk immunosuppressive or cytotoxic therapy, such as rituximab, doxorubicin, or moderate-to-high-dose corticosteroids (≥20 mg/day of prednisone or equivalent) for more than 4 consecutive weeks.
- •Pregnant or breastfeeding women.
- •Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment.
- •Subjects for whom the validity of informed consent is questionable, including those with psychiatric disorders, intellectual disability, poor motivation, or other conditions that may limit their ability to provide informed consent.
结局指标
主要结局
All-Cause Mortality at 90 Days
时间窗: 90 days post-enrollment
Proportion of participants who die from any cause within 90 days following enrollment.
次要结局
- ICU Mortality(ICU stay, assessed up to 90 days)
- In-Hospital Mortality(Hospitalization period, assessed up to 90 days)
- 28-Day All-Cause Mortality(28 days post-enrollment)
- Change in Gut Microbiota Composition(Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT.)
- Change in Fecal Metabolome(Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT)
- Change in serum Metabolome(Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT)
- Serum Citrulline Concentration(Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment)
- Change in Sequential Organ Failure Assessment (SOFA) Score(Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment)
- Change in Acute Physiology and Chronic Health Evaluation II (APACHE II) Score(Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment)
- Cumulative total dose of vasoactive agents(7 days post-enrollment)
- Change in serum level of C-reactive protein (CRP)(Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment)
- Change in serum level of procalcitonin (PCT)(Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment)
- Cumulative Fluid Balance(7 days post-enrollment)
- Incidence of ICU Delirium(Up to 7 days post-enrollment (during ICU stay))
- Incidence of Feeding Intolerance(Up to 7 days post-enrollment (during ICU stay))
- 90-Day Hospital Readmission Rate(90 days post-discharge)
- Incidence of FMT-Related Adverse Events(During the FMT administration period (up to 7 days))
研究者
Jiancheng Zhang
Dr.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology