Liver FailureNCT05170971
Fecal Microbiota Transplantation for Liver Failure
A study testing fecal microbiota transplantation in people with Liver Failure, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial summary
To investigate the safety, adverse reactions and therapeutic effects of fecal microbiota transplantation on patients with liver failure;to investigate the effect of fecal microbiota transplantation on the intestinal microecology and "gut-liver axis immune system" of liver failure, and further optimization of fecal… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Failure
- What is being tested?
- fecal microbiota transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients willing to sign informed consent
- Patients aged 18-65
- According to the diagnosis standard of liver failure in the guide for diagnosis and treatment of liver failure (2018 Edition), the eligible patients are included, that is, on the basis of chronic liver disease, the syndrome with acute jaundice deepening and coagulation dysfunction as the manifestation of liver failure caused by various inducements can be combined with complications such as Hepatoencephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome, etc And extrahepatic organ failure. The patient's jaundice deepened rapidly, the serum TBIL ≥ 10 × ULN or the daily rise ≥ 17.1 μ mol / L; there was bleeding, PTA ≤ 40% (or INR ≥ 1.5)
Who cannot join
- Patients with severe heart failure, COPD, cerebrovascular accident, nephrotic syndrome, etc;
- Patients with gastrointestinal bleeding, pulmonary infection, septicemia, etc
- Patients with liver cancer, lung cancer, lymphoma and other malignant tumors
- Patients taking anticoagulants, mental diseases and immune diseases for a long time
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University
Ningbo, Zhejiang
Xu lanman, +86 13587646315, 13587646315@163.com
About this study
Official title: The Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Acute-on-chronic Liver Failure
To investigate the safety, adverse reactions and therapeutic effects of fecal microbiota transplantation on patients with liver failure;to investigate the effect of fecal microbiota transplantation on the intestinal microecology and "gut-liver axis immune system" of liver failure, and further optimization of fecal microbiota transplantation technology.
- Conditions
- Liver Failure
- Being tested
- fecal microbiota transplantation
- Keywords
- fecal microbiota transplantation, gut-liver axis, liver failure
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantationOther
The fecal bacteria were transplanted once every 5 days for a total of 4 times
| Study group | Role | What they receive |
|---|---|---|
| fecal microbiota transplantation | Other | The fecal bacteria were transplanted once every 5 days for a total of 4 times. Receives: Other: fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function change
The investigators need to monitor the changes in liver and kidney function before and after faecal bacteria transplantation，such as ALT、AST、GGT 、TBIL(The units of these indices are U/L).
Measured: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
Coagulation function change
Prothrombin activity are one of the indexes to evaluate the degree of liver failure in patients.The units of this indices is %.
Measured: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
Model for end-stage liver disease score change
The model for end-stage liver disease (MELD) score is a prospectively developed and validated scale for the severity of end-stage liver disease.The higher the MELD score, the more severe the liver disease and the greater the risk of death. The fatality rate of patients with MELD between 20 and 30 was more than 30%, that of patients with MELD between 30 and 40 was more than 50%, and that of patients with MELD >40 was more than 70%.
Measured: Model for end-stage liver disease score were obtained separately in 1 week before faecal bacteria transplantation, and to access once again at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
gut microbiota change
Gene sequencing and metabonomics analysis of fecal flora.
Measured: Fecal samples were collected 1 week before faecal bacteria transplantation, and change from at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
Observe the clinical manifestations, safety and adverse reactions of the patients
Safety and adverse events were assessed including fever, diarrhea and elevated inflammatory markers (such as C-reactive protein and procalcitonin) before and after faecal bacteria transplantation.
Measured: These indicators were collected 1 week before faecal bacteria transplantation, and change from at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
proinflammatory cytokine change
IL-17,IL-6,TNF-α, TGF-β, IFN-γ and other cytokines were detected by ELISA(The units of these indices are pg/mL).
Measured: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, xulanman, Ningbo Medical Center Lihuili Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170971
- Sponsor's protocol ID
- KJ2019PJ021
- Status last verified
- Mar 2024
- First submitted
- 27 May 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Acute-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT05170971
- Acronym / sponsor ID
- KJ2019PJ021
- Conditions
- Liver Failure
- Keywords
- fecal microbiota transplantation, gut-liver axis, liver failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Dec 2021 (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.
To investigate the safety, adverse reactions and therapeutic effects of fecal microbiota transplantation on patients with liver failure;to investigate the effect of fecal microbiota transplantation on the intestinal microecology and "gut-liver axis immune system" of liver failure, and further optimization of fecal microbiota transplantation technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fecal microbiota transplantation | Other | Other: fecal microbiota transplantationThe fecal bacteria were transplanted once every 5 days for a total of 4 times. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients willing to sign informed consent
- Patients aged 18-65
- According to the diagnosis standard of liver failure in the guide for diagnosis and treatment of liver failure (2018 Edition), the eligible patients are included, that is, on the basis of chronic liver disease, the syndrome with acute jaundice deepening and coagulation dysfunction as the manifestation of liver failure caused by various inducements can be combined with complications such as Hepatoencephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome, etc And extrahepatic organ failure. The patient's jaundice deepened rapidly, the serum TBIL ≥ 10 × ULN or the daily rise ≥ 17.1 μ mol / L; there was bleeding, PTA ≤ 40% (or INR ≥ 1.5)
Key exclusion criteria (5 listed)
- Patients with severe heart failure, COPD, cerebrovascular accident, nephrotic syndrome, etc;
- Patients with gastrointestinal bleeding, pulmonary infection, septicemia, etc
- Patients with liver cancer, lung cancer, lymphoma and other malignant tumors
- Patients taking anticoagulants, mental diseases and immune diseases for a long time
- Pregnant or lactating women.
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 microbiota transplantationThe fecal bacteria were transplanted once every 5 days for a total of 4 times | Other | fecal microbiota transplantation |
Primary outcome
Liver function change
Time frame: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
The investigators need to monitor the changes in liver and kidney function before and after faecal bacteria transplantation，such as ALT、AST、GGT 、TBIL(The units of these indices are U/L).
Coagulation function change
Time frame: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
Prothrombin activity are one of the indexes to evaluate the degree of liver failure in patients.The units of this indices is %.
Model for end-stage liver disease score change
Time frame: Model for end-stage liver disease score were obtained separately in 1 week before faecal bacteria transplantation, and to access once again at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
The model for end-stage liver disease (MELD) score is a prospectively developed and validated scale for the severity of end-stage liver disease.The higher the MELD score, the more severe the liver disease and the greater the risk of death. The fatality rate of patients with MELD between 20 and 30 was more than 30%, that of patients with MELD between 30 and 40 was more than 50%, and that of patients with MELD >40 was more than 70%.
gut microbiota change
Time frame: Fecal samples were collected 1 week before faecal bacteria transplantation, and change from at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
Gene sequencing and metabonomics analysis of fecal flora.
Observe the clinical manifestations, safety and adverse reactions of the patients
Time frame: These indicators were collected 1 week before faecal bacteria transplantation, and change from at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
Safety and adverse events were assessed including fever, diarrhea and elevated inflammatory markers (such as C-reactive protein and procalcitonin) before and after faecal bacteria transplantation.
proinflammatory cytokine change
Time frame: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively
IL-17,IL-6,TNF-α, TGF-β, IFN-γ and other cytokines were detected by ELISA(The units of these indices are pg/mL).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Related trials for Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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.
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 microbiota transplantation in people with Liver Failure, run by Ningbo Medical Center Lihuili 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 5 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: looking for participants now, as of the sponsor's last update on 12 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lanman Xu (+86 13587646315, 13587646315@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver function change (time frame: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.