Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-04

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

fecal bacteria solution

Intervention Type 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 control group with physiological saline

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

Group Type OTHER

physiological saline solution

Intervention Type DRUG

physiological saline solution 20ml

Interventions

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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.

Intervention Type DRUG

physiological saline solution

physiological saline solution 20ml

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No