FMT in Cirrhosis and Hepatic Encephalopathy
Cirrhosis, Hepatic Encephalopathy
About this trial
This is an interventional other trial for Cirrhosis focused on measuring fecal microbial transplant, cirrhosis, hepatic encephalopathy
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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 aged >75 years
- 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 Exclusion Criteria:
Enema-related
- Platelet count<25,000
- Grade IV hemorrhoids
Safety-related:
- Dysphagia
- History of aspiration, gastroparesis, intestinal obstruction
- Ongoing antibiotic use (except for Rifaximin)
- Severe anaphylactic food allergy
- Allergy to ingredients Generally Recognized As Safe in the FMT capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)
- Adverse event attributable to prior FMT
- ASA Class IV or V
- Pregnant or nursing patients
- Acute illness or fever within 48 hours of the day of planned FMT
- Immunocompromised due to medical conditions
- Probiotics use within the last 48 hours of the day of planned FMT
- Any condition that the physician investigators deem unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
Sites / Locations
- Hunter Holmes McGuire VA Medical Center, Richmond, VARecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Active Comparator
Experimental
Placebo
Group 3: Oral placebo and rectal FMT
Group 2: Oral FMT and rectal placebo
Group 1: Dual Oral and rectal FMT
Oral and rectal placebo at visit 2 Oral placebo at day 30
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30