Decompensated CirrhosisPhase 1/2FMTDCNCT03014505
Fecal Microbiota Transplantation for Decompensated Cirrhosis
A Phase 1/2 study testing FMT and traditional treatments in people with Decompensated Cirrhosis and Fecal Microbiota Transplantation, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.
Trial summary
Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Decompensated Cirrhosis, Fecal Microbiota Transplantation
- What is being tested?
- FMT and traditional treatments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jul 2018
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Agreed to participate in this clinical study and signed informed consent, follow-up time greater than 3 months.
- Comply with the diagnostic criteria of decompensated liver cirrhosis, including liver function damage, portal hypertension clinical manifestations, laboratory and imaging studies.
Who cannot join
- Ongoing bacterial infection requiring antibiotic treatment.
- current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average).
- consecutive months within 1 year prior to screening.
- Treatment with antibiotics or probiotics in the preceding 3 months.
- Inability to safely perform an GastroIntestinal endoscopy.
- No history of recent spontaneous bacterial peritonitis or gastrointestinal bleeding.(14 days).
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- Human Immunodeficiency Virus (HIV) infection.
- Active, serious medical disease with likely life expectancy less than 5 years.
- Active substance abuse including inhaled or injection drugs in the year prior to screening.
- pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding.
- Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.
- History of severe (anaphylactic) food allergy.
- History of gastroparesis or altered gastric motility -
- Psychiatric disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
IEC of Chengdu Medical College
Chendu, 610500
Xiao-an Li, doctor, +8613680868858, zqzy1983@163.com
About this study
Official title: Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial
Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.
Read the detailed description
Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months \& subjects will be clinically assessed for improvement or worsening.
- Being tested
- FMT, traditional treatments
- Keywords
- Cirrhosis, Fecal Microbiota Transplantation, Intestinal flora, Intestinal mucosal barrier, Intestinal Bacteria Flora Disturbance
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTBiological
Also called Fecal Microbiota Transplantation
Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1
traditional treatmentsOther
traditional treatments for Decompensated Cirrhosis in part 2
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments Receives: Biological: FMT |
| The traditional treatments | Active comparator | Not described Receives: Other: traditional treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events complication rate in all patients in both groups
Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.
Measured: 3 months
Secondary outcomes (7)
Improvement in liver function test as compared to baseline in both groups.
Measured: 3 months
Reduction in systemic inflammatory markers like TNF-α in both groups.
Measured: 3 months
Reduction in systemic inflammatory markers like IL-6 in both groups.
Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.
Measured: 3 months
Reduction in systemic inflammatory markers like serum endotoxins in both groups.
Measured: 3 months
Diamine oxidase（DAO）
Measured: 3 months
Histological changes in the intestinal biopsy in both groups.
Measured: 3 months
Microbiota composition
Deep sequencing of the microbiota at baseline and post-FMT.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionMar 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao-an Li, Ph.D, Study chair, First Affiliated Hospital of Chengdu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014505
- Sponsor's protocol ID
- FMT-GYH
- Acronym
- FMTDC
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03014505
- Acronym / sponsor ID
- FMTDC / FMT-GYH
- Keywords
- Cirrhosis, Fecal Microbiota Transplantation, Intestinal flora, Intestinal mucosal barrier, Intestinal Bacteria Flora Disturbance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical CollegeUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- 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.
Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.
Detailed description
Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months \& subjects will be clinically assessed for improvement or worsening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT | Experimental | Biological: FMTFecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments |
| The traditional treatments | Active comparator | Other: traditional treatments |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age
- Agreed to participate in this clinical study and signed informed consent, follow-up time greater than 3 months.
- Comply with the diagnostic criteria of decompensated liver cirrhosis, including liver function damage, portal hypertension clinical manifestations, laboratory and imaging studies.
Key exclusion criteria (14 listed)
- Ongoing bacterial infection requiring antibiotic treatment.
- current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average).
- consecutive months within 1 year prior to screening.
- Treatment with antibiotics or probiotics in the preceding 3 months.
- Inability to safely perform an GastroIntestinal endoscopy.
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 |
|---|---|---|
| FMTAlso: Fecal Microbiota TransplantationFecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1 | Biological | FMT |
| traditional treatmentstraditional treatments for Decompensated Cirrhosis in part 2 | Other | The traditional treatments |
Primary outcome
Number of adverse events complication rate in all patients in both groups
Time frame: 3 months
Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.
7 secondary outcomes
Improvement in liver function test as compared to baseline in both groups.
Time frame: 3 months
Reduction in systemic inflammatory markers like TNF-α in both groups.
Time frame: 3 months
Reduction in systemic inflammatory markers like IL-6 in both groups.
Time frame: 3 months
Reduction in systemic inflammatory markers like serum endotoxins in both groups.
Time frame: 3 months
Diamine oxidase（DAO）
Time frame: 3 months
Histological changes in the intestinal biopsy in both groups.
Time frame: 3 months
Microbiota composition
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- 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.
Xiao-an Li, Ph.D study chair
First Affiliated Hospital of Chengdu Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FMT and traditional treatments in people with Decompensated Cirrhosis and Fecal Microbiota Transplantation, run by First Affiliated Hospital of Chengdu Medical College 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 14 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 9 Jan 2017. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yan Zhou, Ph.D (+86-18981941992, zqlvzy319@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events complication rate in all patients in both groups (time frame: 3 months). 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 9 Jan 2017.