FMTFecal Microbiota Transplantation (FMT) in Nonalcoholic Steatohepatitis(NASH). A Pilot Study

Inclusion Criteria:

1) >18 years of age 2) histologic evidence of definite or probable NASH based upon a liver biopsy obtained <90 days prior to enrollment and a NAFLD activity score (NAS) ≥4 with ≥1 in each component of the NAS score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3).

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Exclusion Criteria:

1. current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average)
2. Another form of liver disease
3. Recent antibiotic use within 3 months or need for chronic antibiotic therapy
4. Use of drugs historically associated with NAFLD or drugs known to improve NASH histology such as vitamin E> 400 IU/day or pioglitazone
5. Prior or planned (during the study period) bariatric surgery
6. Uncontrolled diabetes defined as HbA1c 9.5% or higher within 60 days prior to enrollment
7. Presence of cirrhosis on liver biopsy
8. Clinical evidence of hepatic decompensation
9. Inability to safely obtain a liver biopsy or perform an upper endoscopy
10. Human Immunodeficiency Virus (HIV) infection
11. Active, serious medical disease with likely life expectancy less than 5 years
12. Active substance abuse including inhaled or injection drugs in the year prior to screening
13. pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding
14. Participation in an IND trial in the 30 days before randomization
15. Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study
16. History of severe (anaphylactic) food allergy
17. History of inflammatory bowel disease
18. History of gastroparesis or altered gastric motility -