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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The experimental group with FMT | Experimental | 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 |
|
| The control group with physiological saline | Other | The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal bacteria solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Clinical outcome | up to 28 days in ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota distribution assessed by 16SrDNA | 16SrDNA | up to 6 days after fecal microbial transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YuanZhuo Chen | Contact | 13764528213 | chenyuanzhuo@tongji.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| YuanZhuo Chen | Shanghai 10th People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth Hospital | Recruiting | Shanghai | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30250472 | Background | Haak BW, Prescott HC, Wiersinga WJ. Therapeutic Potential of the Gut Microbiota in the Prevention and Treatment of Sepsis. Front Immunol. 2018 Sep 10;9:2042. doi: 10.3389/fimmu.2018.02042. eCollection 2018. | |
| 42174754 | Derived | Chen Y, Zhao J, Zhao J, Chen Q, Dong S, Jia S, Zhao Y, Hao D, Yin Y, Lin S, Chen Y, Zhuang Y, Peng H. Effects of fecal microbiota transplantation and probiotics on the gut microbiome in antibiotic-treated septic patients: A pilot randomized controlled trial. Virulence. 2026 Dec;17(1):2668764. doi: 10.1080/21505594.2026.2668764. Epub 2026 May 22. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| physiological saline solution | Drug | physiological saline solution 20ml |
|