SepsisNCT05578196
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
A study testing fecal bacteria solution and physiological saline solution in people with Sepsis and Infections, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Sepsis, Infections
- What is being tested?
- fecal bacteria solution and physiological saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth Hospital
Shanghai, 200000
Yuanzhuo Chen, MD, chenyuanzhuo021@hotmail.com
About this study
Official title: Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Sepsis, Infections
- Being tested
- fecal bacteria solution, physiological saline solution
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal bacteria solutionDrug
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.
physiological saline solutionDrug
physiological saline solution 20ml
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: physiological saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Clinical outcome
Measured: up to 28 days in ICU
Secondary outcomes (1)
Gut microbiota distribution assessed by 16SrDNA
16SrDNA
Measured: up to 6 days after fecal microbial transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start4 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yuanzhuo, Shanghai 10th People's Hospital
- Investigators
- YuanZhuo Chen, Study chair, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578196
- Sponsor's protocol ID
- FMT20220925
- Status last verified
- May 2024
- First submitted
- 25 Sep 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30250472Chen Y, Zhao J, Zhao J, Chen Q, Dong S, Jia S, Zhao Y, Hao D, Yin Y, Lin S, Chen Y, Zhuang Y, Peng H. Effects of fecal microbiota transplantation and probiotics on the gut microbiome in antibiotic-treated septic patients: A pilot randomized controlled trial. Virulence. 2026 Dec;17(1):2668764. doi: 10.1080/21505594.2026.2668764. Epub 2026 May 22.
PubMed 42174754
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05578196
- Acronym / sponsor ID
- FMT20220925
- Conditions
- Sepsis, Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 4 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group with FMT | Experimental | Drug: fecal bacteria solutionThe 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 | Other | Drug: physiological saline solutionThe gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal bacteria solutionThe 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 | The experimental group with FMT |
| physiological saline solutionphysiological saline solution 20ml | Drug | The control group with physiological saline |
Primary outcome
Death
Time frame: up to 28 days in ICU
Clinical outcome
1 secondary outcome
Gut microbiota distribution assessed by 16SrDNA
Time frame: up to 6 days after fecal microbial transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 30250472Haak 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.
- Derived from this study: PubMed 42174754Chen Y, Zhao J, Zhao J, Chen Q, Dong S, Jia S, Zhao Y, Hao D, Yin Y, Lin S, Chen Y, Zhuang Y, Peng H. Effects of fecal microbiota transplantation and probiotics on the gut microbiome in antibiotic-treated septic patients: A pilot randomized controlled trial. Virulence. 2026 Dec;17(1):2668764. doi: 10.1080/21505594.2026.2668764. Epub 2026 May 22.
- Individual participant dataSharing planned: No
Related trials for Sepsis
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YuanZhuo Chen study chair
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fecal bacteria solution and physiological saline solution in people with Sepsis and Infections, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YuanZhuo Chen (13764528213, chenyuanzhuo@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: up to 28 days in ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05578196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.