CompletedPhase 1/2

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

Canada4 participantsStarted 2014-07-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

Portion of participants with normailzation of ICT or Stroop Test during the study

Timeframe: 8 weeks

Trial details

NCT IDNCT02255617

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-25

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