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Completed

NCT Number: NCT02255617

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

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.

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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–65 year

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 and Stroop as well as serum ammonia levels.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • abnormal inhibitory control test, defined as greater than 5 lures.
  • an infectious etiology which may cause HE has been ruled out

Exclusion criteria

  • those with tense ascites
  • those who do not provide assent
  • those who are judged to have a life expectancy of less than 3 months,
  • those who had TIPS within 3 months,
  • those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
  • pregnancy
  • those with intestinal obstruction
  • those with alcoholic hepatitis
  • those with active alcohol or substance abuse
  • those without stable social support
  • those who have a concurrent infection, such as SBP, pneumonia or UTI
  • those with creatinine clearance less than 50% compared to baseline
  • those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy

Treatment and study plan

Fecal Microbiota Transplant

Biological

Fecal transplant processed from routinely screened universal donors

Primary outcomes

  1. Portion of participants with normailzation 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

  4. Changes in Intestinal Microbiota pre and post FMT

    Time frame: 8 weeks

  5. Serious Adverse Events

    Time frame: 8 weeks

    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. Changes in stool bile acids composition pre and post FMT

    Time frame: 8 Weeks

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2014
Registry last updated
Oct 4, 2021

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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