Actively Recruiting
The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial
Led by University of Chicago · Updated on 2025-11-04
24
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of liver disease, liver failure, and/or cirrhosis
- Currently hospitalized with a hepatology consult in place
- Diagnosis confirmed by labs, liver biopsy, clinical or radiologic evidence of liver disease
- Admitted for hepatic decompensation
- MELD score 30 or less at time of enrollment
- Low fecal metabolite levels: butyrate 64 700�b5M and deoxycholate 64 10�b5M
You will not qualify if you...
- MELD score greater than 30 at enrollment
- Receiving any antibiotics for infection treatment
- Chronic or prophylactic antibiotic use other than rifaximin, ciprofloxacin, or trimethoprim-sulfamethoxazole
- Rifaximin use that cannot be paused or switched during treatment
- Currently admitted to ICU for vasoactive support or mechanical ventilation
- Acute-on-chronic liver failure with 2 or more organ failures
- Known intestinal barrier dysfunction or active gastrointestinal disorders
- Profound immunocompromise including primary immunodeficiency, transplant, cancer treatment, neutropenia, untreated HIV, or immunosuppressive medications
- Delayed gastrointestinal motility with 2 or fewer bowel movements per week
- Allergic to both ampicillin/sulbactam and meropenem
- Allergy to investigational products or components
- Liver disease caused by Hepatitis C
- Existing inflammatory arthritis
- History of total colectomy
- Not planning to continue care at University of Chicago for at least 6 months
- Untreated psychiatric conditions affecting follow-up
- Inability to participate as judged by care team
- Women of childbearing age without negative pregnancy test and effective birth control
- Concurrent use of other investigational drugs or live biotherapeutic products
- Use of ACE-inhibitors with certain bacterial consortia requires closer blood pressure monitoring
- Use of metformin requires medication change or more frequent Vitamin B12 monitoring
- Vitamin B12 deficiency must be treated as needed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
M
Matthew A Odenwald, MD, PhD
CONTACT
C
Christopher Lehmann, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here