Status:
COMPLETED
FMT in Cirrhosis and Hepatic Encephalopathy
Lead Sponsor:
VA Office of Research and Development
Conditions:
Cirrhosis
Hepatic Encephalopathy
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not re...
Detailed Description
Indication: Cirrhosis and hepatic encephalopathy Study Objectives: To evaluate the safety and tolerability of fecal transplant in patients with cirrhosis and hepatic encephalopathy Rationale and Sup...
Eligibility Criteria
Inclusion
- Cirrhosis diagnosed by either of the following in a patient with chronic liver disease
- Liver Biopsy
- Radiologic evidence of varices, cirrhosis or portal hypertension
- Laboratory evidence of platelet count \<100,000 or AST/ALT ratio\>1
- Endoscopic evidence of varices or portal gastropathy
- Fibroscan values suggestive of cirrhosis
- On treatment for hepatic encephalopathy (patient can be on lactulose and rifaximin)
- Able to give written, informed consent (demonstrated by mini-mental status exam\>25 at the time of consenting)
- Women of child bearing potential must agree to use effective contraception for the duration of the study and for 10 days prior and 30 days after the study
- Negative pregnancy test in women of childbearing age
Exclusion
- MELD score \>22
- WBC count \<1000 cells/mm3
- Platelet count\<25,000/mm3
- TIPS in place for less than a month
- Currently on antibiotics apart from rifaximin
- Infection at the time of the FMT (diagnosed by blood culture positivity, urinalysis, paracentesis as needed)
- Hospitalization for any non-elective cause within the last 1 month
- Patients who are pregnant or nursing (will be checked using a urine pregnancy test)
- Patients who are incarcerated
- Patients who are incapable of giving their own informed consent
- Patients who are immuno-compromised due to the following reasons:
- HIV infection (any CD4 count)
- Inherited/primary immune disorders
- Current or recent (\<3 mos) treatment with anti-neoplastic agent
- Current or recent (\<3 mos) treatment with any immunosuppressant medications \[including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil\].
- Subjects who are otherwise immunocompetent and have discontinued any immunosuppressant medications 3 or more months prior to enrollment may be eligible to enroll
- Patients on renal replacement therapy
- Patients with untreated, in-situ colorectal cancer
- Patients with a history of chronic intrinsic GI diseases such as inflammatory bowel disease
- ulcerative colitis, Crohn's disease or microscopic colitis
- eosinophilic gastroenteritis or celiac disease
- Major gastro-intestinal or intra-abdominal surgery in the last three months
- Other
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03796598
Start Date
July 29 2019
End Date
December 20 2023
Last Update
May 25 2025
Active Locations (1)
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1
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249-0001