A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes of inflammatory factors in the two groups
研究概览
简要总结
A total of 30 hospitalized patients with COVID-19 over 60 years old were enrolled in this study and were divided into the experimental group (n=15) and the control group (n=15) at a ratio of 1:1. Both groups were treated according to the 2022 Shanghai guidelines for Diagnosis and Treatment of COVID-19 infection and the hierarchical diagnosis and treatment process. The experimental group was treated with fecal microbiota transplantation (FMT) capsules for 1 week, and the control group was treated with empty capsules. Patients in both groups were followed up for 1 month after discharge. To observe the effect of combined FMT capsule treatment on the regulation of inflammatory factors in peripheral blood and the remodeling of intestinal flora, and to verify its safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 60 years old, male or female;
- •Meet the diagnostic criteria of COVID-19;
- •The patient signed the informed consent, agreed to receive FMT capsule treatment, agreed to cooperate with the whole process of the clinical trial, and agreed to collect clinical data and blood, saliva, urine, stool and other samples;
- •The patient was able to swallow 3# capsules by herself.
排除标准
- •Confirmed diagnosis of non-COVID19 pneumonia;
- •Critically ill patients requiring mechanical ventilation, or patients who are unable to eat by mouth and swallow 3# capsules;
- •Patients who had undergone gastrointestinal surgery;
- •Presence of intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc.
- •Pathological intestinal inflammatory changes, such as inflammatory bowel disease;
- •Planned use of antacids, probiotics, antibiotics, FMT and other treatments affecting intestinal flora within the past 3 months or the following 2 months;
- •Patients and their families did not agree to receive FMT treatment;
- •Patients unable to cooperate with follow-up visits.
研究组 & 干预措施
FMTgroup
干预措施: Fecal microbiota transplantation (Procedure)
control gtoup
结局指标
主要结局
Changes of inflammatory factors in the two groups
时间窗: 7day,1month
The changes of inflammatory factors in the transplantation group were detected compared with the control group
次要结局
未报告次要终点
研究者
Huanlong Qin
chief physician
Shanghai 10th People's Hospital