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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Tenth Hospital
RECRUITING
Shanghai
Contact Information
Primary
YuanZhuo Chen
chenyuanzhuo@tongji.edu.cn
13764528213
Time Frame
Start Date: 2022-09-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 110
Treatments
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
Other: The control group with physiological saline
The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml
Related Therapeutic Areas
Sponsors
Leads: Shanghai 10th People's Hospital

This content was sourced from clinicaltrials.gov