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Fecal Microbiome Transplantation in Cirrhosis. Randomized, Double-blinded, Placebo-Controlled trial in patients with decompensated cirrhosis.
EU CTIS ID: 2023-509151-13-00
What this study is testing
To evaluate the efficacy of fecal microbiome trasplantation (FMT) in halting the progression of decompensated cirrhosis as assessed by the time to first incidence decompensated episode during study period.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 of duration of the study). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
You likely can't join if
- Previous history of gastrointestinal surgery or colorectal cancer.
- Patients with ACLF according to the criteria published by Moreau et al.
- 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.
See the full eligibility criteria
Who can 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 of duration of the study). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
What rules you out
- Previous history of gastrointestinal surgery or colorectal cancer.
- Patients with ACLF according to the criteria published by Moreau et al.
- 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 tumors 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.
- Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.
- Refusal to give informed consent.
- 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.
- 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: a. Bacterial infection within 10 days before study inclusion. b. Gastrointestinal bleeding within 10 days before study inclusion. c. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.