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

Inclusion Criteria:

1. Age ≥ 18 years old.

2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/orhistology. Cirrhosis of any etiology may be included except from patients withcirrhosis due to autoimmune hepatitis, and patients with cirrhosis due tocholestatic liver disease can only be included in the study if they present clinicaldecompensation 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 serumbefore the inclusion in the study and agree to use highly effective contraceptivemethods during the study. Highly effective contraceptive methods will include:intrauterine device, bilateral tubal occlusion, vasectomized partner and sexualabstinence** (only if refraining from heterosexual intercourse during the period oftwelve months). Hormonal contraceptive methods will be avoided due to the risk ofadverse 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 atincreased risk of this complication.

3. Active Clostridium Difficile infection.

4. Patients on treatment with non-selective beta-blockers for <3 month or withoutstable 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-0or BCLC-A) or patients with previous history of HCC and absence of recurrence 2years after treatment.

9. Patients admitted to the hospital for acute decompensation of the disease. Thesepatients could be included after discharged as long as they do not present any ofthe following events:

10. Bacterial infection within 10 days before study inclusion.

11. Gastrointestinal bleeding within 10 days before study inclusion.

12. Current overt hepatic encephalopathy, defined as grade II-IV hepaticencephalopathy according to the New-Haven classification.

13. Patients with ACLF according to the criteria published by Moreau et al. (Appendix 1).

14. Severe alcoholic hepatitis requiring corticosteroid therapy (MELD > 20) in the last 6 months.

15. Patients with active alcohol consumption of more than 21 units per week.

16. HIV infection.

17. Patients with a history of significant extra hepatic disease with impairedshort-term prognosis, including congestive heart failure New York Heart AssociationGrade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL orunder renal replacement therapy.

18. Patients with current extra hepatic malignancies including solid tumours andhematologic disorders.

19. Patients with previous organ transplantation.

20. Pregnancy or breastfeeding.

21. Patients included in other clinical trials in the month before inclusion.

22. Patients with mental incapacity, language barrier, bad social support or any otherreason considered by the investigator precluding adequate understanding, cooperationor compliance in the study.

23. Refusal to give informed consent.