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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 : October 25, 2019
Rebiotix Inc.
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Biological: FMT Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy
Actual Study Start Date : April 12, 2016
Estimated Primary Completion Date : April 12, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: FMT
Open label FMT administered at week 0 by colonoscopy and weeks 1-4 by enema
Biological: FMT
FMT processed from routinely screened donors

Primary Outcome Measures :
  1. Time to HE breakthrough [ Time Frame: 9 weeks ]
    Duration from FMT to overt HE

Secondary Outcome Measures :
  1. ICT [ Time Frame: 9 weeks ]
    Changes in ICT

  2. Stroop [ Time Frame: 9 weeks ]
    Changes in Stroop test

  3. Ammonia [ Time Frame: 9 weeks ]
    Changes in serum ammonia level

  4. Quality of Life [ Time Frame: 9 weeks ]
    Changes in Chronic Liver Disease Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03439982

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Contact: Dina Kao, MD 780 492 8307

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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Dina Kao, MD    780 492 8307   
Sponsors and Collaborators
University of Alberta
Rebiotix Inc.
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Principal Investigator: Dina Kao, MD Associate Professor
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Responsible Party: University of Alberta Identifier: NCT03439982    
Other Study ID Numbers: Pro00060782
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Hepatic encephalopathy, fecal microbiota transplant
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases