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Fecal Microbial Transplant for Hepatic Encephalopathy
Study Summary
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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your MELD score is higher than 22.Your white blood cell count is less than 1000 cells per cubic millimeter.Your platelet count is less than 25,000 per cubic millimeter.You have very low platelet count or severe hemorrhoids.You had a TIPS procedure done within the last month.You have a weakened immune system because of HIV, inherited immune disorders, or recent treatment for cancer.You had a significant surgery in your belly area in the last three months.You are currently being treated for a condition called hepatic encephalopathy, and are taking lactulose and rifaximin.You are currently taking any antibiotics except rifaximin.You have an infection when the FMT procedure is scheduled.You have taken medications that weaken your immune system in the last three months.You are receiving treatment for kidney problems.You have colorectal cancer that has not been treated yet.Women who could become pregnant must have a negative pregnancy test.You have a history of certain long-term stomach and intestine diseases like ulcerative colitis, Crohn's disease, or celiac disease.You have been diagnosed with cirrhosis using different tests such as liver biopsy, imaging tests, blood tests, or Fibroscan.You have difficulty swallowing, history of stomach or intestine problems, ongoing severe allergies, or certain medical conditions that make it unsafe for you to participate.
- Group 1: Group 1: Dual Oral and rectal FMT
- Group 2: Placebo
- Group 3: Group 2: Oral FMT and rectal placebo
- Group 4: Group 3: Oral placebo and rectal FMT
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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"
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."
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."
Does this trial include individuals above the age of majority?
"Per the outlined stipulations, only individuals aged 21 to 75 may join this trial."
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