The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
Qualifiers
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.
Labs demonstrating elevated liver chemistries (AST and ALT), elevated serum bilirubin levels, prolonged INR, or radiologic evidence of cirrhosis (e.g. nodular liver contour);
Disqualifiers
MELD score >30 at time of enrollment
Patients receiving any antibiotics for treatment of an infection.
Chronic or prophylactic antibiotic administration other than rifaximin, ciprofloxacin, or trimethoprim-sulfamethoxazole.
Patients who are currently admitted to the intensive care unit for vasoactive support or mechanical ventilation.
Trial design
Treatments tested in this trial
- Commensal Bacteria Strains
Treatment groups
24 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov