Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

Not Applicable

Recruiting

• Conditions: Sepsis; Infections
• Interventions: Drug: physiological saline solution; Drug: fecal bacteria solution

• Registration Number: NCT05578196
• Lead Sponsor: Shanghai 10th People's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-09-04
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group with physiological saline	physiological saline solution	The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml
The experimental group with FMT	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

Primary Outcome Measures

Name	Time	Method
Death	up to 28 days in ICU	Clinical outcome

Secondary Outcome Measures

Name	Time	Method
Gut microbiota distribution assessed by 16SrDNA	up to 6 days after fecal microbial transplantation	16SrDNA

Trial Locations

Locations (1)

Shanghai Tenth Hospital; 🇨🇳 Shanghai, China