Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis

Launched by CONSORCIO CENTRO DE INVESTIGACIÓN BIOMÉDICA EN RED (CIBER) · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Fecal Microbiota Transplantation (FMT) for patients with decompensated cirrhosis, which is a serious liver condition where the liver cannot function properly. The goal of the trial is to see if FMT, which involves transferring healthy gut bacteria from a donor to the patient, is safe and helpful for improving liver health. This study will take place at multiple sites, and it is a "double-blind" trial, meaning that neither the participants nor the doctors know who is receiving the treatment or a placebo (a non-active treatment) until the study is complete.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with cirrhosis, which could be caused by various factors but not by autoimmune hepatitis or certain types of liver diseases unless they have specific symptoms. Women who can become pregnant will need to take a pregnancy test before joining and agree to use effective birth control during the study. Participants can expect regular check-ups and monitoring throughout the trial to ensure their safety and to see how well the treatment works. It’s important to note that certain individuals, such as those with active infections or specific medical conditions, will not be able to participate to keep everyone safe.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years old.
• • 2. 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).
• • 3. Child-Pugh B or C patients (7- up to 12 points).
• • 4. 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.
• Exclusion Criteria:
• • 1. Previous history of gastrointestinal surgery or colorectal cancer.
• • 2. Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.
• • 3. Active Clostridium Difficile infection.
• • 4. Patients on treatment with non-selective beta-blockers for \<3 month or without stable doses.
• • 5. Patients on treatment with any immunosuppressive drugs.
• • 6. Patients on antiviral therapy for HCV or those who have received it within the last 12 months.
• • 7. Patients on antiviral therapy for HBV therapy for \< 12 months.
• • 8. 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.
• 9. 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:
• • 1. Bacterial infection within 10 days before study inclusion.
• • 2. Gastrointestinal bleeding within 10 days before study inclusion.
• • 3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification.
• • 10. Patients with ACLF according to the criteria published by Moreau et al. (Appendix 1).
• • 11. Severe alcoholic hepatitis requiring corticosteroid therapy (MELD \> 20) in the last 6 months.
• • 12. Patients with active alcohol consumption of more than 21 units per week.
• • 13. HIV infection.
• • 14. 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.
• • 15. Patients with current extra hepatic malignancies including solid tumours and hematologic disorders.
• • 16. Patients with previous organ transplantation.
• • 17. Pregnancy or breastfeeding.
• • 18. Patients included in other clinical trials in the month before inclusion.
• • 19. 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.
• • 20. Refusal to give informed consent.