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Completed

NCT Number: NCT03439982

Fecal Transplant for Hepatic Encephalopathy

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.

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alberta Hospital

Edmonton, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMT

Biological

FMT processed from routinely screened donors

Primary outcomes

  1. Portion of participants with normalization of ICT or Stroop Test during the study

    Time frame: 8 weeks

Secondary outcomes

  1. Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8

    Time frame: 8 weeks

  2. Changes in serum ammonia level pre and post FMT

    Time frame: 8 weeks

  3. Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT

    Time frame: 8 weeks

    29 Questions Total- each question is on a seven point scales, ranging from the worst (1) to the best (7) possible function

  4. Change in Intestinal Microbiota pre-and post FMT

    Time frame: 8 weeks

  5. Serious Adverse Events

    Time frame: 8 weeks

    i) All serious adverse events up to and including week 8. A serious adverse event is any event which results in any of the following: i) Death ii) Colonic perforation iii) Proven infections as defined by the presence of i) spontaneous bacteremia: positive blood cultures in the absence of any other potential source of infection; ii) spontaneous bacterial peritonitis: ascetic fluid PMN equal to or greater than 250/mm3; iii) UTI: urinary leukocyte count greater than 15 cells per HPF and positive urine culture; vi) other infections identified by clinical, radiologic and bacteriologic results.

    iv) Possible infections as defined by i) fever (temp > 37.80 C), ii) leukocytosis (>15,000 mm3) or increased immature neutrophils in blood (>500 mm3), negative cultures and no other signs of infection.

  6. Change in stool Bile Acids Composition pre and post FMT

    Time frame: 8 Weeks

  7. Changes in stool short chain free fatty acids pre and post FMT

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Rebiotix Inc.

Registry information

Official study title

A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Feb 20, 2018
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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