A Phase 1/2 interventional study of FMT in Hepatic Encephalopathy, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by University of Alberta · Phase 1/2, Interventional, and Treatment
Among 11 studies in Hepatic Encephalopathy with a site in Canada — 1 open to participants now, 2 under way, 1 of them phase 3. Hepatic Encephalopathy · Canada.
Among the 11 studies in Hepatic Encephalopathy with a site in Canada, this one is the only one that started in 2016, is one of 2 in phase 1/2, and was the 6th registered.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
Browse Hepatic Encephalopathy studies →1 of the 11 studies in Hepatic Encephalopathy with a site in Canada is open now. Recruiting first, the newest first:
Prof. Valérie Mc Lin · Sites in Canada, United States, Australia and 13 more countries
Ages 1 days+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 30 Hepatic Encephalopathy studies recruiting now, 12 (40%) set no upper age limit and 13 (43%) stop at 75 or younger; 1 takes children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 4
First in 2000; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 60 across 154 interventional studies indexed under Hepatic Encephalopathy.
Median enrollment 106 across the 8 interventional studies, 158 across the 3 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 11 have an industry lead sponsor. The 6 most frequent:
University of Alberta is the lead sponsor of 824 studies on the registry; 170 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
University of Alberta has 3 studies filed under Hepatic Encephalopathy — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Hepatic Encephalopathy with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open label FMT administered at week 0 by colonoscopy and weeks 1-4 by enema
Biological: FMT
FMT processed from routinely screened donors
Portion of participants with normalization of ICT or Stroop Test during the study
Time frame: 8 weeks
Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8
Time frame: 8 weeks
Changes in serum ammonia level pre and post FMT
Time frame: 8 weeks
Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT
29 Questions Total- each question is on a seven point scales, ranging from the worst (1) to the best (7) possible function
Time frame: 8 weeks
Change in Intestinal Microbiota pre-and post FMT
Time frame: 8 weeks
Serious Adverse Events
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.
Time frame: 8 weeks
Change in stool Bile Acids Composition pre and post FMT
Time frame: 8 Weeks
Changes in stool short chain free fatty acids pre and post FMT
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2016 to primary completion in Aug 2019, 39 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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