Clinical trial

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

Name
FMT20220925
Description
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.
Trial arms
Trial start
2022-09-04
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Recruiting
Treatment
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.
Arms:
The experimental group with FMT
physiological saline solution
physiological saline solution 20ml
Arms:
The control group with physiological saline
Size
110
Primary endpoint
Death
up to 28 days in ICU
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2024-05-17

1 organization

2 products

2 indications

Indication
Sepsis
Indication
Infections