FMT for decompensated cirrhosis: a multicenter phase 3 test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. Participants with decompensated cirrhosis (Child-Pugh B or C) will be assigned to receive either fecal microbiota transplantation from healthy donors or a placebo. The study aims to assess safety and efficacy of FMT in improving clinical outcomes in this population. Eligible adults include patients with cirrhosis of various etiologies, excluding autoimmune-related cirrhosis, with decompensation defined by ascites or other criteria. The trial is conducted at major Barcelona hospitals under a collaborative sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Clínic de Barcelona
  Barcelona, Spain Recruiting
• Hospital de la Santa Creu i Sant Pau
  Barcelona, Spain Recruiting
• Hospital Universitari Vall Hebron
  Barcelona, Spain Recruiting
• Hospital General Universitario Gregorio Marañón
  Madrid, Spain Recruiting
• Hospital General Universitario Puerta de Hierro
  Madrid, Spain Recruiting
• Hospital Universitario Ramón y Cajal
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Eva Bonfill
• Email: BONFILL@recerca.clinic.cat
• Phone: +34932275400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.