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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
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    September 25, 2022
    Last Updated
    October 12, 2022
    Sponsor
    Shanghai 10th People's Hospital
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    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
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    Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

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