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New treatment option for Decompensated Cirrhosis
Official title Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis
ClinicalTrials.gov ID: NCT06533852
What this study is testing
What is Fecal Microbiome Transplantation (FMT)?
Fecal Microbiome Transplantation (FMT) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for decompensated cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- 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...
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Madrid, Spain
- Sabadell, Spain
- Santander, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Madrid, Spain; Sabadell, Spain; Santander, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.