Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial

Conditions
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Sepsis, Infections

Intervention / Treatment
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* Drug: fecal bacteria solution
* Drug: physiological saline solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental group with FMT<br>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<br>* 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.<br>|
| Other: The control group with physiological saline<br>The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml | Drug: physiological saline solution<br>* physiological saline solution 20ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Clinical outcome | up to 28 days in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota distribution assessed by 16SrDNA | 16SrDNA | up to 6 days after fecal microbial transplantation |