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

NCT02469272 | Unknown Phase 1 DMC

• 1 other identifier: Committee # 2014-15
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• degree of hepatic steatosis as determined by MRI

  12 weeks

Secondary Outcomes (2)

• Liver Function Tests

  12 weeks

• Markers of insulin sensitivity

  12 weeks

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

Intervention: standardized preparation of frozen fecal material from lean healthy donors Route: infused into the duodenum through the working channel of the instrument at upper endoscopy Dosing: 1 dose

Drug: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation DRUG

Administration of frozen fecal materials into gastrointestinal tract

Also known as: FMT

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) \>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).

You may not qualify if:

• 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)
• Another form of liver disease
• Recent antibiotic use within 3 months or need for chronic antibiotic therapy
• Use of drugs historically associated with NAFLD or drugs known to improve NASH histology such as vitamin E\> 400 IU/day or pioglitazone
• Prior or planned (during the study period) bariatric surgery
• Uncontrolled diabetes defined as HbA1c 9.5% or higher within 60 days prior to enrollment
• Presence of cirrhosis on liver biopsy
• Clinical evidence of hepatic decompensation
• Inability to safely obtain a liver biopsy or perform an upper endoscopy
• Human Immunodeficiency Virus (HIV) infection
• Active, serious medical disease with likely life expectancy less than 5 years
• Active substance abuse including inhaled or injection drugs in the year prior to screening
• pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding
• Participation in an IND trial in the 30 days before randomization
• Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study

Sponsors & Collaborators

• Lifespan: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (2)

• Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.

  PMID: 24890442 BACKGROUND

• Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20.

  PMID: 22728514 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Kittichai Promrat, M.D.

  Lifespan

  PRINCIPAL INVESTIGATOR

• Colleen Kelly, M.D.

  Lifespan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Turnbull, RN

CONTACT

401-444-7344; rturnbull@lifespan.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

US (1)