Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hepatic Encephalopathy, Cirrhosis, Liver

In brief

Individuals with cirrhosis are likely to develop overt hepatic encephalopathy for which diagnostic modalities and treatment options are limited. The purpose of this study is to determine if individuals with cirrhosis who experience hepatic encephalopathy would benefit from investigational microbiota restoration therapy due to their inherent cognitive alterations. Analysis for a correlation between changes in microbiome composition and specific blood biomarkers could allow for earlier diagnosis of HE which could then be treated earlier and with novel treatments.

Key facts

Study ID

NCT04155099

Run by

Ochsner Health System

People needed

5

Starts

2021-03-01

Expected to finish

2023-07-30

Last updated by the study team

2023-10-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals who are male or female and are between the ages of 18 and 70 years.
• Individuals with a current diagnosis of liver cirrhosis as evidenced by one or more of the following:
• a. Liver Biopsy
• OR a clinical suspicion of cirrhosis based on the presence of one or more of the following criteria:
• 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
• Elastography (i.e. Fibroscan)
• Individuals must have at least one previously documented episode of HE.
• Individuals must be able to read and write in the English language.
• Individuals must be able and willing to utilize the electronic device necessary to measure cognitive function without assistance from outside individuals once the training phase has been completed.
• Individuals must be able to provide valid informed consent prior to any study related procedures.

You may not qualify if…

• Individuals who are color-blind.
• Individuals actively using psychotropic substances including alcohol.
• Individuals who are pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Study individuals are expected to attest to this fact during their participation time. Females who are not surgically sterile or having undergone greater than one year of menopause will receive urine pregnancy tests at screening and initial drug dosing.
• Presence of TIPS (transjugular intrahepatic portosystemic shunt).
• Individuals with an active bacterial infection and are taking antibiotics for those infections at time of consent.
• Individuals with ANC <800 (neutropenia).
• Individuals with MELD >17.
• Individuals with platelet count <35,000/mm3.
• Individuals who are immunocompromised due any of the following reasons:
• HIV infection (CD4 count <200/mm3) or AIDS diagnosis
• Inherited/primary immunodeficiency disorders
• Treatment with any anti-neoplastic agent within the last 3 months (excluding locoregional therapy for hepatocellular carcinoma)
• Treatment with any immunosuppressant medications [including but not limited to monoclonal antibodies to B cells or T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil] within the last 3 months
• Individuals who have previously undergone FMT.
• Individuals with a history of colorectal cancer (all stages).
• Individuals 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 as determined by Rome III criteria.
• Individuals with a history of colectomy, major gastro-intestinal surgery, or intra-abdominal surgery.
• Individuals with a history of Clostridium difficile infection six months prior to study enrollment.
• Individuals with a history of chronic diarrhea.
• Individuals currently participating in a research trial that involves drug or device intervention.
• Individuals who are unable to fulfill all study criteria.
• Individuals that the PI determines are not capable of participating in the research study.

Where it is running

• Ochsner Medical Center — Jefferson, Louisiana, United States

Full record on ClinicalTrials.gov

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