Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Sepsis
• Intervention / Treatment: Drug: fecal bacteria solution; Drug: physiological saline solution

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YuanZhuo Chen; Phone Number: 13764528213; Email: chenyuanzhuo@tongji.edu.cn

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Shanghai Tenth Hospital
    • Contact: Yuanzhuo Chen, MD; Email: chenyuanzhuo021@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.
Other: The control group with physiological saline; The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml	Drug: physiological saline solution; physiological saline solution 20ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Clinical outcome	up to 28 days in ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota distribution assessed by 16SrDNA	16SrDNA	up to 6 days after fecal microbial transplantation

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: YuanZhuo Chen, Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Pharmaceutical Solutions
• Other Study ID Numbers: FMT20220925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No