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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplant | Experimental | Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant | Biological | Fecal transplant processed from routinely screened universal donors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Portion of participants with normailzation of ICT or Stroop Test during the study | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8 | 8 weeks | |
| Changes in serum ammonia level pre and post FMT | 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | Canada |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT |
| 8 weeks |
| Changes in Intestinal Microbiota pre and post FMT | 8 weeks |
| Serious Adverse Events | 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. | 8 weeks |
| Changes in stool bile acids composition pre and post FMT | 8 Weeks |
| Changes in stool short chain fatty acids pre and post FMT | 8 weeks |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |