Fecal Transplant in Recurrent Hepatic Encephalopathy

Completed · Phase 1

Conditions studied: Hepatic Encephalopathy, Cirrhosis

In brief

Randomized, open-label safety, tolerability study with exploratory endpoints and pathophysiological evaluation of the FMT Two groups of outpatients with cirrhosis will be randomized using random sequence generator into no-treatment and FMT groups.

Key facts

Study ID

NCT02636647

Run by

Jasmohan Bajaj

People needed

20

Starts

2015-10-01

Expected to finish

2016-08-01

Last updated by the study team

2022-07-05

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• At least two episodes of hepatic encephalopathy, one within the last year but not within the last month (patient can be on lactulose and rifaximin)
• Age between 21 and 75
• Able to give written, informed consent (demonstrated by mini-mental status exam>25 at the time of consenting)

You may not qualify if…

• MELD score >17
• WBC count <1000 cells/mm3
• Platelet count<50,000/mm3
• On the liver transplant list
• TIPS in place
• No HE episode within a month prior to the study
• Patients allergic to ciprofloxacin, penicillins or metronidazole
• Currently on absorbable antibiotics
• 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 3 months
• 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 with a history of severe (anaphylactic) food allergy
• Patients who have previously undergone FMT
• Patients on renal replacement therapy
• Patients who are unwilling or unable to hold the enemas
• 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, celiac disease or irritable bowel syndrome

Where it is running

• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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