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Fecal Transplant for Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03439982
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Rebiotix Inc.
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date February 20, 2018
Actual Study Start Date  ICMJE April 12, 2016
Estimated Primary Completion Date April 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
Time to HE breakthrough [ Time Frame: 9 weeks ]
Duration from FMT to overt HE
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • ICT [ Time Frame: 9 weeks ]
    Changes in ICT
  • Stroop [ Time Frame: 9 weeks ]
    Changes in Stroop test
  • Ammonia [ Time Frame: 9 weeks ]
    Changes in serum ammonia level
  • Quality of Life [ Time Frame: 9 weeks ]
    Changes in Chronic Liver Disease Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Fecal Transplant for Hepatic Encephalopathy
Official Title  ICMJE A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy
Brief Summary The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.
Detailed Description Subjects receive FMT from a single donor by colonoscopy at week 0 and by enema at weeks 1-4. HE is measured by Inhibitory Control Test (ICT) and Stroop test as well as fasting serum ammonia levels.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatic Encephalopathy
Intervention  ICMJE Biological: FMT
FMT processed from routinely screened donors
Study Arms  ICMJE Experimental: FMT
Open label FMT administered at week 0 by colonoscopy and weeks 1-4 by enema
Intervention: Biological: FMT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 12, 2022
Estimated Primary Completion Date April 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis
  • Abnormal ICT (>5 lures) or abnormal Stroop test (>200 seconds)
  • Baseline Conn score 0 or 1
  • Infectious etiology of HE has been ruled out

Exclusion Criteria:

  • those with tense ascites
  • those who do not provide assent
  • life expectancy <3 months
  • TIPS within the past 3 months
  • neurologic disease such as dementia, Parkinson's, structural brain lesions
  • pregnancy
  • intestinal obstruction
  • alcoholic hepatitis
  • active alcohol or substance abuse
  • those without stable social support
  • concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection
  • creatinine clearance less that 50% compared to baseline
  • hospital admission for HE within one month of enrollment
  • active hepatocellular carcinoma
  • active GI bleed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dina Kao, MD 780 492 8307
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03439982
Other Study ID Numbers  ICMJE Pro00060782
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Rebiotix Inc.
Investigators  ICMJE
Principal Investigator: Dina Kao, MD Associate Professor
PRS Account University of Alberta
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP