Decompensated CirrhosisPhase 3LiverGutNCT06533852
Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis
A Phase 3 study testing Fecal Microbiome Transplantation (FMT) in people with Decompensated Cirrhosis, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 8 sites in Spain.
Trial summary
This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Fecal Microbiome Transplantation (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 8 sitesSpain
- Study dates
- 16 Jul 2025to Jan 2029
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included except from patients with cirrhosis due to autoimmune hepatitis, and patients with cirrhosis due to cholestatic liver disease can only be included in the study if they present clinical decompensation of cirrhosis (i.e. ascites).
- Child-Pugh B or C patients (7- up to 12 points).
- Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence** (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
Who cannot join
- Previous history of gastrointestinal surgery or colorectal cancer.
- Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.
- Active Clostridium Difficile infection.
- Patients on treatment with non-selective beta-blockers for <3 month or without stable doses.
- Patients on treatment with any immunosuppressive drugs.
- Patients on antiviral therapy for HCV or those who have received it within the last 12 months.
Show all 23Show fewer
- Patients on antiviral therapy for HBV therapy for < 12 months.
- Patients with hepatocellular carcinoma, except for patients with early HCC (BCLC-0 or BCLC-A) or patients with previous history of HCC and absence of recurrence 2 years after treatment.
- Patients admitted to the hospital for acute decompensation of the disease. These patients could be included after discharged as long as they do not present any of the following events:
- Bacterial infection within 10 days before study inclusion.
- Gastrointestinal bleeding within 10 days before study inclusion.
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification.
- Patients with ACLF according to the criteria published by Moreau et al. (Appendix 1).
- Severe alcoholic hepatitis requiring corticosteroid therapy (MELD > 20) in the last 6 months.
- Patients with active alcohol consumption of more than 21 units per week.
- HIV infection.
- Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
- Patients with current extra hepatic malignancies including solid tumours and hematologic disorders.
- Patients with previous organ transplantation.
- Pregnancy or breastfeeding.
- Patients included in other clinical trials in the month before inclusion.
- Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
- Refusal to give informed consent.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Spain8 sites, 8 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Pere Gines Gibert, MD-PhD
Adria Juanola Mayos, MD-PhD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
German Soriano Pastor, MD-PhD
- Recruiting
Hospital Universitari Vall Hebron
Barcelona
Isabel Campos Varela, MD-PhD
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
Rafael Bañares Cañizares, MD-PhD
- Recruiting
Hospital General Universitario Puerta de Hierro
Madrid
Carlos Fernández Carrillo, MD-PhD
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Agustion Albillos Martínez, MD-PhD
- Recruiting
Corporació Sanitaria Universitaria Parc Taulí
Sabadell
Cristina Solé Martó, MD-PhD
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander
Jose Ignacio Fortea Ormachea, MD-PhD
About this study
Official title: Fecal Microbiome Transplantation in Cirrhosis: Randomized, Double-blinded, Placebo-Controlled Trial in Patients With Decompensated Cirrhosis
This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis.
- Conditions
- Decompensated Cirrhosis
- Being tested
- Fecal Microbiome Transplantation (FMT), FMT Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiome Transplantation (FMT)Drug
Two doses:
First dose: 24 capsules of FMT at baseline. Second dose: 24 capsules of FMT at 3 months.
FMT PlaceboOther
Two doses:
First dose: 24 capsules of FMT placebo at baseline. Second dose: 24 capsules of FMT placebo at 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiome Transplantation (FMT) | Experimental | A first dose of 24 capsules of FMT at baseline and a second dose of 24 capsules of FMT at 3 months. Each dose (24 capsules) contains approximately 50g of stool. Receives: Drug: Fecal Microbiome Transplantation (FMT) |
| FMT Placebo | Placebo comparator | A first dose of 24 capsules of FMT placebo at baseline and a second dose of 24 capsules of FMT placebo at 3 months. Each dose (24 capsules) contains in total 6 g of microcrystalline cellulose or equivalent. Receives: Other: FMT Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment in halting the progression of decompensated cirrhosis.
Assessed by time to first decompensation event (acute kidney injury (AKI), ascites, bacterial infection, gastrointestinal bleeding, HE).
Measured: Screening to month 12.
Secondary outcomes (26)
Time to transplant-free survival
Assessed by transplant-free survival
Measured: At month 1, month 3, month 6 and month 12
Mortality rates
Assessed by mortality rates
Measured: At month 1, month 3, month 6 and month 12
Rate of patients developing/ worsening individual complications of cirrhosis.
Assessed by ascites, acute kidney injury, bacterial infections, gastrointestinal bleeding and hepatic encephalopathy.
Measured: At baseline, month 1, month 3, month 6 and month 12.
Frequency of hospital admissions due to complications of cirrhosis.
Assessed by hospital admissions due to complications of cirrhosis.
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Development of acute-on-chronic liver failure (ACLF)
Assessed by time to first episode of ACLF
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Development of acute-on-chronic liver failure (ACLF)
Assessed by total number of patients developing ACLF
Measured: At month 3, month 6 and month 12.
Development of acute-on-chronic liver failure (ACLF)
Assessed by severity of ACLF episodes based on ACLF grade (from grade 1 to grade 3) and CLIF-C-ACLF score
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Development of acute-on-chronic liver failure (ACLF)
Assessed by number and type of organ failures
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in systemic inflammatory response.
Evaluated by measurement in a large array of plasma cytokine levels including, but not limited to TNFα, IL-6, IL8, IL-10, IL-1β, IFN-ɣ, G-CSF, VCAM, VEGF, as well as an oxidized form of albumin, human nonmercaptalbumin-2 (HNA2).
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
PBMCs phenotype and function.
Analysed by flow cytometry, functional analysis, and RNAseq single cell analysis.
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in different plasma and urine prognostic biomarkers.
Measurated by different plasma and urine prognostic biomarkers including, but not only, copeptin, NGAL, PD-L1, L-FABP.
Measured: At baseline, 1 month, 3 months, 6 months, and 12 months.
Changes from baseline in systemic hemodynamics and vasoactive hormones.
Measurated by systemic hemodynamics and vasoactive hormones: plasma renin concentration and plasma copeptin.
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in blood levels of bacterial DNA or bacterial products.
Measurated by blood levels of bacterial DNA or bacterial products.
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in liver function.
Evaluated by MELD (Model for End-stage Liver Disease) score.
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in liver function.
Evaluated by CLIF-AD score.
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in liver function.
Evaluated by Child Pugh Score.(from 1 point to 15 points)
Measured: At baseline, 1 month, 3 months, 6 months and 12 months.
Analyze microbiome composition from saliva and stool.
Measurated by analysis of microbial genes.
Measured: At baseline, and months 1, 3 and 6.
Changes in hepatic venous pressure gradient (HVPG) from baseline.
Measurated by the hepatic venous pressure gradient.
Measured: At baseline and month 6.
Assess Quality of life, functional assessment and in Minimal Hepatic Encephalopathy.
Evaluated with data obtained from CLDQ (Chronic Liver Disease Questionnaire) questionnaire.
Measured: At baseline, 3 months, 6 months and 12 months.
Assess Quality of life, functional assessment and in Minimal Hepatic Encephalopathy.
Evaluated with data obtained from Liver Frailty Index.
Measured: At baseline, 3 months, 6 months and 12 months.
Assess Quality of life, functional assessment and in Minimal Hepatic Encephalopathy.
Evaluated with data obtained from PHES (Psychometric Hepatic Encephalopathy Score) questionnaire.
Measured: At baseline, 3 months, 6 months and 12 months.
Changes from baseline in AUDIT test.
Evaluated from AUDIT test
Measured: AUDIT test at baseline, 3 months, 6 months and 12 months
Changes from baseline in alcohol consumption.
Evaluated from PETh measurament.
Measured: PETh measurament test at baseline, 1 month, 3 months, 6 months and 12 months.
Assess the effect of FMT in ECG (Electrocardiogram).
Evaluated by changes in ACE score.
Measured: At screening, baseline and months 3,6 and 12.
Proportion of patients with treatment-related adverse events.
Evaluated by treatment-related adverse events.
Measured: Screening to month 12.
Proportion of patients with severe treatment-related adverse events.
Evaluated by treatment-related adverse events.
Measured: Screening to month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start16 Jul 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533852
- Sponsor's protocol ID
- 2023-509151-13-00
- Other IDs
- 2023
- Acronym
- LiverGut
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiome Transplantation in Cirrhosis: Randomized, Double-blinded, Placebo-Controlled Trial in Patients With Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT06533852
- Acronym / sponsor ID
- LiverGut / 2023-509151-13-00
- Conditions
- Decompensated Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 1 Aug 2024 (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.
This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiome Transplantation (FMT) | Experimental | Drug: Fecal Microbiome Transplantation (FMT)A first dose of 24 capsules of FMT at baseline and a second dose of 24 capsules of FMT at 3 months. Each dose (24 capsules) contains approximately 50g of stool. |
| FMT Placebo | Placebo comparator | Other: FMT PlaceboA first dose of 24 capsules of FMT placebo at baseline and a second dose of 24 capsules of FMT placebo at 3 months. Each dose (24 capsules) contains in total 6 g of microcrystalline cellulose or equivalent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included except from patients with cirrhosis due to autoimmune hepatitis, and patients with cirrhosis due to cholestatic liver disease can only be included in the study if they present clinical decompensation of cirrhosis (i.e. ascites).
- Child-Pugh B or C patients (7- up to 12 points).
- Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence** (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
Key exclusion criteria (23 listed)
- Previous history of gastrointestinal surgery or colorectal cancer.
- Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.
- Active Clostridium Difficile infection.
- Patients on treatment with non-selective beta-blockers for <3 month or without stable doses.
- Patients on treatment with any immunosuppressive drugs.
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 Microbiome Transplantation (FMT)Two doses: First dose: 24 capsules of FMT at baseline. Second dose: 24 capsules of FMT at 3 months. | Drug | Fecal Microbiome Transplantation (FMT) |
| FMT PlaceboTwo doses: First dose: 24 capsules of FMT placebo at baseline. Second dose: 24 capsules of FMT placebo at 3 months. | Other | FMT Placebo |
Primary outcome
Efficacy of treatment in halting the progression of decompensated cirrhosis.
Time frame: Screening to month 12.
Assessed by time to first decompensation event (acute kidney injury (AKI), ascites, bacterial infection, gastrointestinal bleeding, HE).
26 secondary outcomes
Time to transplant-free survival
Time frame: At month 1, month 3, month 6 and month 12
Mortality rates
Time frame: At month 1, month 3, month 6 and month 12
Rate of patients developing/ worsening individual complications of cirrhosis.
Time frame: At baseline, month 1, month 3, month 6 and month 12.
Frequency of hospital admissions due to complications of cirrhosis.
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Development of acute-on-chronic liver failure (ACLF)
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Development of acute-on-chronic liver failure (ACLF)
Time frame: At month 3, month 6 and month 12.
Development of acute-on-chronic liver failure (ACLF)
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Development of acute-on-chronic liver failure (ACLF)
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in systemic inflammatory response.
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
PBMCs phenotype and function.
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in different plasma and urine prognostic biomarkers.
Time frame: At baseline, 1 month, 3 months, 6 months, and 12 months.
Changes from baseline in systemic hemodynamics and vasoactive hormones.
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in blood levels of bacterial DNA or bacterial products.
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in liver function.
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in liver function.
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Changes from baseline in liver function.
Time frame: At baseline, 1 month, 3 months, 6 months and 12 months.
Analyze microbiome composition from saliva and stool.
Time frame: At baseline, and months 1, 3 and 6.
Changes in hepatic venous pressure gradient (HVPG) from baseline.
Time frame: At baseline and month 6.
Assess Quality of life, functional assessment and in Minimal Hepatic Encephalopathy.
Time frame: At baseline, 3 months, 6 months and 12 months.
Assess Quality of life, functional assessment and in Minimal Hepatic Encephalopathy.
Time frame: At baseline, 3 months, 6 months and 12 months.
Assess Quality of life, functional assessment and in Minimal Hepatic Encephalopathy.
Time frame: At baseline, 3 months, 6 months and 12 months.
Changes from baseline in AUDIT test.
Time frame: AUDIT test at baseline, 3 months, 6 months and 12 months
Changes from baseline in alcohol consumption.
Time frame: PETh measurament test at baseline, 1 month, 3 months, 6 months and 12 months.
Assess the effect of FMT in ECG (Electrocardiogram).
Time frame: At screening, baseline and months 3,6 and 12.
Proportion of patients with treatment-related adverse events.
Time frame: Screening to month 12.
Proportion of patients with severe treatment-related adverse events.
Time frame: Screening to month 12.
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 20 Jul 2026.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fecal Microbiome Transplantation (FMT) in people with Decompensated Cirrhosis, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 8 sites in Spain.
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 4 inclusion and 23 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eva Bonfill (+34932275400 ext. 4198, BONFILL@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment in halting the progression of decompensated cirrhosis. (time frame: Screening to month 12.). 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 20 Jul 2026.