The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial
University of Chicago
Summary
The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) trial is a single center prospective adaptive phase 1b clinical trial in patients who are hospitalized with complications of liver disease and have low fecal metabolite levels (butyrate and deoxycholic acid). The study intervention is 1 of 9 novel live Commensal Consortia each containing eight commensal bacterial strains derived from healthy donors. The primary objective of the study is to determine safety and tolerability of Commensal Consortia administration.
Description
The global burden of chronic liver disease (CLD) continues to rise. CLD is often clinically silent until an initial decompensation event, after which care is largely supportive without the ability to significantly modify the underlying disease with current therapies. Due to the high rates of infection in patients with liver disease, empiric, broad spectrum antibiotics are commonly prescribed. This practice is associated with altered gut microbiome compositions, reduced levels of health-promoting bacterial metabolites and high levels of antibiotic resistant organisms, findings that correlate wi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years or older * Diagnosis of liver disease, liver failure, and/or cirrhosis * All patients will be hospitalized and have a hepatology consult in place. * They will be identified as having liver disease, liver failure, and/or cirrhosis based on a combination of at least one of the following: * Labs demonstrating elevated liver chemistries (AST and ALT), elevated serum bilirubin levels, prolonged INR, or radiologic evidence of cirrhosis (e.g. nodular liver contour); * Liver biopsy results; and/or * Clinical or radiologic evidence of portal hypertension (e.g.…
Interventions
- BiologicalCommensal Bacteria Strains
7 doses containing 7 capsules will be administered over 7-10 days
Location
- The University of Chicago Medical CenterChicago, Illinois