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

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Nonalcoholic steatohepatitis (NASH) is common, may progress to cirrhosis and is predicted to become a leading indication for liver transplantation in the near future. Though often associated with obesity and the metabolic syndrome, our current understanding of disease development is limited and there are few therapeutic options. Imbalance of gut bacteria is suspected to play a key role driving the progression of fatty liver disease and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation, using stool from lean donors, is an effective and safe treatment for NASH.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lifespan

Criteria

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 -