Cirrhosis, LiverFMTNCT04591522
Fecal Microbiota Transplantation in Cirrhosis
A study testing Healthy fecal bacteria liquid in people with Cirrhosis, Liver, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
Patients with cirrhosis were recruitted and divided into cintrol group and FMT group. Patients in FMT group were carried by fecal microbiota transplantation, and biochemical indexes, intestinal flora and intestinal HIF expression were observed before and after FMT respectively. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Healthy fecal bacteria liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to 30 Jun 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cirrhotic
- aged 18-80 years.
- must be able to cooperate with treatment
Who cannot join
- Patients with severe cardiac, pulmonary and renal dysfunction;
- Patients with severe hypertension and cerebrovascular accidents;
- Patients with liver cancer or active infection are in the active stage of hepatic encephalopathy or gastrointestinal bleeding;
- Prothrombin activity ≤40%, platelet count < 50*10^9/L;
- Patients with intellectual and language disorders and mental disorders;
- Probiotics with antibiotic and drug grade were used within 3 months prior to sampling;
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- There are prehepatic or posthepatic portal hypertension reasons;
- Drug history: anticoagulant therapy, use of antiplatelet drugs, and current use of beta blockers, statins or interferon (IFN) treatment;
- Peptic colon examination contraindications, such as intestinal perforation, intestinal obstruction, etc.
- Other researchers believe that patients should not be included in the group.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Study of HIF-1α in Cirrhosis by Fecal Microbiota Transplantation
Patients with cirrhosis were recruitted and divided into cintrol group and FMT group. Patients in FMT group were carried by fecal microbiota transplantation, and biochemical indexes, intestinal flora and intestinal HIF expression were observed before and after FMT respectively.
- Conditions
- Cirrhosis, Liver
- Being tested
- Healthy fecal bacteria liquid
- Keywords
- Cirrhosis；fecal Microbiota Transplantation
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy fecal bacteria liquidOther
Fecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine.
| Study group | Role | What they receive |
|---|---|---|
| FMT group | Experimental | Patients were carried by fecal microbiota transplantation which described in detail that fecal bacteria are extracted from the faeces of healthy people and poured into the intestines of patients. Receives: Other: Healthy fecal bacteria liquid |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood ammonia
blood ammonia in umol/L
Measured: Change from baseline blood ammonia at 12 months
alanine aminotransferase
alanine aminotransferase in U/L
Measured: Change from baseline alanine aminotransferase at 12 months
aspartate aminotransferase
aspartate aminotransferase in U/L
Measured: Change from baseline aspartate aminotransferase at 12 months
gut microbiome
16S RNA sequencing in gut microbiome
Measured: Change from baseline gut microbiome at 12 months
white blood cell
white blood cell in /L
Measured: Change from baseline white blood cell at 12 months
hemoglobin
hemoglobin in g/L
Measured: Change from baseline hemoglobin at 12 months
blood platelet
blood platelet in/L
Measured: Change from baseline blood platelet at 12 months
albumin
albumin in g/L
Measured: Change from baseline albumin at 12 months
blood glucose
blood glucose in mmol/L
Measured: Change from baseline blood glucose at 12 months
Serum creatinine
Serum creatinine in umol/L
Measured: Change from baseline serum creatinine at 12 months
direct bilirubin
direct bilirubin in umol/L
Measured: Change from baseline direct bilirubin at 12 months
indirect bilirubin
indirect bilirubin in umol/L
Measured: Change from baseline indirect bilirubin at 12 months
prothrombin time activity percentage
prothrombin time activity percentage in %
Measured: Change from baseline prothrombin time activity percentage at 12 months
liver stiffness
liver stiffness in Kpa
Measured: Change from baseline liver stiffness at 12 months
Secondary outcomes (1)
Concentration of HIF-1α in intestine
Concentration of HIF-1α expression in intestine by western blot
Measured: Change from baseline HIF-1α expression in intestine at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yongping Chen, Prof, Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591522
- Sponsor's protocol ID
- Yongping_Chen
- Acronym
- FMT
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung CM, Lin YF, Chen KF, Ke HM, Huang HY, Gong YN, Tsai WS, You JF, Lu MJ, Cheng HT, Lin CY, Kuo CJ, Tsai IJ, Hsieh SY. Predicting Clinical Outcomes of Cirrhosis Patients With Hepatic Encephalopathy From the Fecal Microbiome. Cell Mol Gastroenterol Hepatol. 2019;8(2):301-318.e2. doi: 10.1016/j.jcmgh.2019.04.008. Epub 2019 Apr 18.
PubMed 31004827
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of HIF-1α in Cirrhosis by Fecal Microbiota Transplantation
- ClinicalTrials.gov ID
- NCT04591522
- Acronym / sponsor ID
- FMT / Yongping_Chen
- Conditions
- Cirrhosis, Liver
- Keywords
- Cirrhosis；fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Oct 2020 (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.
Patients with cirrhosis were recruitted and divided into cintrol group and FMT group. Patients in FMT group were carried by fecal microbiota transplantation, and biochemical indexes, intestinal flora and intestinal HIF expression were observed before and after FMT respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT group | Experimental | Other: Healthy fecal bacteria liquidPatients were carried by fecal microbiota transplantation which described in detail that fecal bacteria are extracted from the faeces of healthy people and poured into the intestines of patients. |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of cirrhotic
- aged 18-80 years.
- must be able to cooperate with treatment
Key exclusion criteria (10 listed)
- Patients with severe cardiac, pulmonary and renal dysfunction;
- Patients with severe hypertension and cerebrovascular accidents;
- Patients with liver cancer or active infection are in the active stage of hepatic encephalopathy or gastrointestinal bleeding;
- Prothrombin activity ≤40%, platelet count < 50*10^9/L;
- Patients with intellectual and language disorders and mental disorders;
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 |
|---|---|---|
| Healthy fecal bacteria liquidFecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine. | Other | FMT group |
Primary outcome
blood ammonia
Time frame: Change from baseline blood ammonia at 12 months
blood ammonia in umol/L
alanine aminotransferase
Time frame: Change from baseline alanine aminotransferase at 12 months
alanine aminotransferase in U/L
aspartate aminotransferase
Time frame: Change from baseline aspartate aminotransferase at 12 months
aspartate aminotransferase in U/L
gut microbiome
Time frame: Change from baseline gut microbiome at 12 months
16S RNA sequencing in gut microbiome
white blood cell
Time frame: Change from baseline white blood cell at 12 months
white blood cell in /L
hemoglobin
Time frame: Change from baseline hemoglobin at 12 months
hemoglobin in g/L
blood platelet
Time frame: Change from baseline blood platelet at 12 months
blood platelet in/L
albumin
Time frame: Change from baseline albumin at 12 months
albumin in g/L
blood glucose
Time frame: Change from baseline blood glucose at 12 months
blood glucose in mmol/L
Serum creatinine
Time frame: Change from baseline serum creatinine at 12 months
Serum creatinine in umol/L
direct bilirubin
Time frame: Change from baseline direct bilirubin at 12 months
direct bilirubin in umol/L
indirect bilirubin
Time frame: Change from baseline indirect bilirubin at 12 months
indirect bilirubin in umol/L
prothrombin time activity percentage
Time frame: Change from baseline prothrombin time activity percentage at 12 months
prothrombin time activity percentage in %
liver stiffness
Time frame: Change from baseline liver stiffness at 12 months
liver stiffness in Kpa
1 secondary outcome
Concentration of HIF-1α in intestine
Time frame: Change from baseline HIF-1α expression in intestine at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Results publication: PubMed 31004827Sung CM, Lin YF, Chen KF, Ke HM, Huang HY, Gong YN, Tsai WS, You JF, Lu MJ, Cheng HT, Lin CY, Kuo CJ, Tsai IJ, Hsieh SY. Predicting Clinical Outcomes of Cirrhosis Patients With Hepatic Encephalopathy From the Fecal Microbiome. Cell Mol Gastroenterol Hepatol. 2019;8(2):301-318.e2. doi: 10.1016/j.jcmgh.2019.04.008. Epub 2019 Apr 18.
- Individual participant dataSharing planned: No
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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.
yongping Chen, Prof principal investigator
First Affiliated Hospital of Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Healthy fecal bacteria liquid in people with Cirrhosis, Liver, run by First Affiliated Hospital of Wenzhou Medical University.
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 10 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Yongping Chen, Prof (+8613505777281, did@wzhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood ammonia (time frame: Change from baseline blood ammonia at 12 months). The study lists 14 primary outcomes in all. 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 NCT04591522, which also lists 1 linked publication.
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 19 Oct 2020.