Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05578196
Collaborator
(none)
110
2
36

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: fecal bacteria solution
  • Drug: physiological saline solution
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Death [up to 28 days in ICU]

    Clinical outcome

Secondary Outcome Measures

  1. Gut microbiota distribution assessed by 16SrDNA [up to 6 days after fecal microbial transplantation]

    16SrDNA

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chen Yuanzhuo, associate chief physician, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT05578196
Other Study ID Numbers:
  • FMT20220925
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2022