Sepsis, Infections
Conditions
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.
Interventions
DRUGfecal bacteria solution
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.
physiological saline solution 20ml
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | up to 28 days in ICU | Clinical outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota distribution assessed by 16SrDNA | up to 6 days after fecal microbial transplantation | 16SrDNA |
Countries
China
Contacts
Primary ContactYuanZhuo Chen
Outcome results
None listed