Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

Tongji University

Status: Enrolling

Conditions: Infections; Sepsis

Treatments: Drug: fecal bacteria solution; Drug: physiological saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05578196

FMT20220925

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

The experimental group with FMT

Experimental group

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

Treatment:

Drug: fecal bacteria solution

The control group with physiological saline

Other group

Description:

The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml

Treatment:

Drug: physiological saline solution