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NCT05578196 Clinical Trial

Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05578196
Other study ID # FMT20220925
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 4, 2022
Est. completion date December 31, 2025

Study information
Verified date May 2024
Source Shanghai 10th People's Hospital
Contact YuanZhuo Chen
Phone 13764528213
Email chenyuanzhuo@tongji.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: - Patients diagnosed with severe infections, which is infected patients SAFA=2 OR APACHE ?=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.

Study Design

Related Conditions & MeSH terms

Intervention

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.
• physiological saline solution
physiological saline solution 20ml

Locations
Country Name City State
China Shanghai Tenth Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Death Clinical outcome up to 28 days in ICU
Secondary Gut microbiota distribution assessed by 16SrDNA 16SrDNA up to 6 days after fecal microbial transplantation
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