This trial is testing a new way to treat confusion in patients with end stage liver disease or cirrhosis, by replacing their bowel bacteria with healthy stool from another person.
- Liver Cirrhosis
- Liver Encephalopathy
1 Primary · 6 Secondary · Reporting Duration: 6 months
4 Treatment Groups
Group 2: Oral FMT and rectal placebo
1 of 4
Group 3: Oral placebo and rectal FMT
1 of 4
Group 1: Dual Oral and rectal FMT
1 of 4
1 of 4
60 Total Participants · 4 Treatment Groups
Primary Treatment: Fecal Microbial Transplant Enema · Has Placebo Group · Phase 1 & 2
Who is running the clinical trial?
Age 21 - 75 · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
Could I be accepted as a participant in this medical trial?
"This clinical trial is recruiting 60 adults between the ages of 21 and 75 that have been diagnosed with hepatic coma. In addition to this prerequisite, female participants must agree to use reliable contraceptive measures from 10 days prior to their involvement in the study until 30 days after its completion. Also, these patients must meet one or more of the following criteria: Liver Biopsy/Radiologic evidence for varices/cirrhosis/portal hypertension, Platelet count <100K or AST/ALT ratio>1, Endoscopic proof for portal gastropathy/varices, Fibroscan values suggestive of cirrhosis on treatment for" - Anonymous Online Contributor
To what extent is the participant pool for this clinical trial expanding?
"Affirmative. The database of clinicaltrials.gov divulges that this analysis is currently searching for research subjects, with the first post having been made on July 29th 2019 and its most recent update being recorded on March 23rd 2022. 60 people are required to be enrolled at a single site." - Anonymous Online Contributor
Are there any vacancies for enrolment in this experiment?
"Verified. According to clinicaltrials.gov, this medical trial is still enrolling participants; it was first advertised on July 29th 2019 and its details were last modified on March 23rd 2022. The study requires 60 individuals from a single hospital site." - Anonymous Online Contributor
Does this trial include individuals above the age of majority?
"Per the outlined stipulations, only individuals aged 21 to 75 may join this trial." - Anonymous Online Contributor