Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

NCT05578196 | Recruiting DMC

• 1 other identifier: FMT20220925
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Infections

Outcome Measures

Primary Outcomes (1)

• Death

  Clinical outcome

  up to 28 days in ICU

Secondary Outcomes (1)

• Gut microbiota distribution assessed by 16SrDNA

  up to 6 days after fecal microbial transplantation

Study Arms (2)

The experimental group with FMT

EXPERIMENTAL

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 control group with physiological saline

OTHER

The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml

Drug: physiological saline solution

Interventions

fecal bacteria solution DRUG

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 experimental group with FMT

physiological saline solution DRUG

physiological saline solution 20ml

The control group with physiological saline

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth Hospital

Shanghai, 200000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30250472 BACKGROUND

MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• YuanZhuo Chen

  Shanghai 10th People's Hospital

  STUDY CHAIR

Central Study Contacts

YuanZhuo Chen

CONTACT

13764528213; chenyuanzhuo@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 13, 2022
• Study Start: September 4, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)