Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
Primary Purpose
Sepsis, Infections
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fecal bacteria solution
physiological saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
The experimental group with FMT
The control group with physiological saline
Arm 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
The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml
Outcomes
Primary Outcome Measures
Death
Clinical outcome
Secondary Outcome Measures
Gut microbiota distribution assessed by 16SrDNA
16SrDNA
Full Information
NCT ID
NCT05578196
First Posted
September 25, 2022
Last Updated
October 12, 2022
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05578196
Brief Title
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
Official Title
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The experimental group with FMT
Arm Type
Experimental
Arm 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
Arm Title
The control group with physiological saline
Arm Type
Other
Arm Description
The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml
Intervention Type
Drug
Intervention Name(s)
fecal bacteria solution
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
physiological saline solution
Intervention Description
physiological saline solution 20ml
Primary Outcome Measure Information:
Title
Death
Description
Clinical outcome
Time Frame
up to 28 days in ICU
Secondary Outcome Measure Information:
Title
Gut microbiota distribution assessed by 16SrDNA
Description
16SrDNA
Time Frame
up to 6 days after fecal microbial transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YuanZhuo Chen
Phone
13764528213
Email
chenyuanzhuo@tongji.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30250472
Citation
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.
Results Reference
background
Learn more about this trial
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
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