Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: fecal 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.
|
Other: The control group with physiological saline The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml |
Drug: physiological saline solution
physiological saline solution 20ml
|
Outcome Measures
Primary Outcome Measures
- Death [up to 28 days in ICU]
Clinical outcome
Secondary Outcome Measures
- Gut microbiota distribution assessed by 16SrDNA [up to 6 days after fecal microbial transplantation]
16SrDNA
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with severe infections, which is infected patients SAFA≥2 OR APACHE Ⅱ≥15
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Aged ≥14 years
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Patients or their family members agreed to participate in this study
Exclusion Criteria:
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Advanced tumors or diseases associated with systemic immunosuppression
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Pregnant women
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Patients with severe intestinal ulcer or perforation
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Unable to complete oral administration and no effective artificial feeding pipeline.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai 10th People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- FMT20220925