An interventional study of fecal bacteria solution and physiological saline solution in Sepsis and Infections, sponsored by Shanghai 10th People's Hospital. Recruiting at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 110 is close to the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
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
Drug: fecal bacteria solution
The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml
Drug: physiological saline 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
Death
Clinical outcome
Time frame: up to 28 days in ICU
Gut microbiota distribution assessed by 16SrDNA
16SrDNA
Time frame: up to 6 days after fecal microbial transplantation
Plan to share: No
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Shanghai 10th People's Hospital