Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Death
Study Overview
Brief Summary
Fecal microbial transplantation is to transplant functional microbiota from the feces of healthy people into the gastrointestinal tract of patients, reconstruct new intestinal microbiota, and realize the treatment of intestinal and extra-intestinal diseases. Compared with ordinary commercial probiotics, FMT is more consistent with the composition of the intestinal microecological structure and can recover intestinal flora to the maximum extent and faster. FMT increases intestinal bacteria production function and helps to restore the systemic immune response so that sepsis pathogens are removed. The aim of this trial was to investigate the clinical effect of FMT in the treatment of patients with severe infections.
Detailed Description
The gastrointestinal tube access was established, and the standard preparation of fecal bacteria solution 20ml (frozen at -80 ° C, melted at room temperature before use) was injected through the gastrointestinal tube once a day for 6 consecutive days. The other treatment measures were the same as those of the control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with severe infections, which is infected patients SAFA≥2 OR APACHE Ⅱ≥15
- •Aged ≥14 years
- •Patients or their family members agreed to participate in this study
Exclusion Criteria
- •Advanced tumors or diseases associated with systemic immunosuppression
- •Pregnant women
- •Patients with severe intestinal ulcer or perforation
- •Unable to complete oral administration and no effective artificial feeding pipeline.
Arms & Interventions
The experimental group with FMT
The gastrointestinal tube access was established, and the standard preparation of fecal bacteria solution 20ml (frozen at -80 ° C, melted at room temperature before use) was injected through the gastrointestinal tube once a day for 6 consecutive days. The other treatment measures were the same as those of the control group
Intervention: fecal bacteria solution (Drug)
The control group with physiological saline
The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml
Intervention: physiological saline solution (Drug)
Outcomes
Primary Outcomes
Death
Time Frame: up to 28 days in ICU
Clinical outcome
Secondary Outcomes
- Gut microbiota distribution assessed by 16SrDNA(up to 6 days after fecal microbial transplantation)
Investigators
Chen Yuanzhuo
associate chief physician
Shanghai 10th People's Hospital