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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Commensal Bacteria Strains
Biological/Vaccine7 doses containing 7 capsules will be administered over 7-10 days
Treatment groups
24 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Commensal Consortium AExperimental treatment 1 intervention
Group B: Commensal Consortium B1Experimental treatment 1 intervention
Group C: Commensal Consortium B2Experimental treatment 1 intervention
Group D: Commensal Consortium C1Experimental treatment 1 intervention
Group E: Commensal Consortium C2Experimental treatment 1 intervention
Group F: Commensal Consortium D1Experimental treatment 1 intervention
Group G: Commensal Consortium D2Experimental treatment 1 intervention
Group H: Commensal Consortium E1Experimental treatment 1 intervention
Group I: Commensal Consortium E2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of adverse events (AEs and SAEs) attributable to the Commensal Consortia
Adverse events will be monitored for 1 year after Commensal Consortium administration using in-person contact, telephone calls and/or Patient-Reported Outcomes
Time frame
Day 1- Month 122
Patient-Reported Outcomes Measurement Information System (PROMIS) scores after Commensal Consortia administration
Tolerability will be assessed for 1 year after Commensal Consortium administration through completion of PROMIS surveys. Surveys will be obtained by the investigators using in-person contact, telephone calls and/or Patient-Reported Outcomes.
Time frame
Day 1- Month 12Secondary outcomes
1
The presence of administered bacterial strains in fecal samples
Stool samples will be collected at regular intervals and subjected to shotgun metagenomic sequencing. Strain engraftment will be defined as detection of the administered strains.
Time frame
Day 1- Month 12Other outcomes
1
Metabolite concentrations in fecal samples
Concentrations of targeted metabolites will be measured in fecal samples collected at regular intervals after Commensal Consortium administration.
Time frame
Day 1- Month 12Sponsors and contacts
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Source ClinicalTrials.gov