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Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255617
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dina Kao, University of Alberta

Tracking Information
First Submitted Date  ICMJE August 26, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE July 23, 2014
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
Time to hepatic encephalopathy breakthrough [ Time Frame: 6 months ]
duration from FMT to overt hepatic encephalopathy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02255617 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Official Title  ICMJE A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Brief Summary The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (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 and Stroop as well as 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: Fecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donors
Study Arms  ICMJE Experimental: Fecal Microbiota Transplant
Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema
Intervention: Biological: Fecal Microbiota Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 19, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2014)
30
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. adult (age > 18 years of age) cirrhotic patients of various etiology, on lactulose and/or rifaximin or flagyl for at least 4 weeks as secondary prophylaxis
  2. abnormal inhibitory control test, defined as greater than 5 lures.
  3. an infectious etiology which may cause HE has been ruled out

Exclusion Criteria:

  1. those with tense ascites
  2. those who do not provide assent
  3. those who are judged to have a life expectancy of less than 3 months,
  4. those who had TIPS within 3 months,
  5. those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
  6. pregnancy
  7. those with intestinal obstruction
  8. those with alcoholic hepatitis
  9. those with active alcohol or substance abuse
  10. those without stable social support
  11. those who have a concurrent infection, such as SBP, pneumonia or UTI
  12. those with creatinine clearance less than 50% compared to baseline
  13. those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255617
Other Study ID Numbers  ICMJE 47057
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dina Kao, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alberta
Verification Date August 2019

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