The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial

Recruiting now · Phase 1

Conditions studied: Liver Diseases, Liver Failure, Cirrhosis, Liver

In brief

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.

Key facts

Study ID

NCT06871111

Run by

University of Chicago

People needed

24

Starts

2025-08-04

Expected to finish

2028-02-04

Last updated by the study team

2025-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. splenomegaly, known varices, ascites, or hepatic venous pressure gradient ≥ 10mmHg).
• All diagnoses will be confirmed by the attending hepatologist's interpretation and consult note attestation.
• Admitted to the hospital for hepatic decompensation
• MELD score ≤ 30 at time of enrollment
• Subject has ≤ 700µM butyrate and ≤ 10µM deoxycholate in fecal sample

You may not qualify if…

• 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.
• Rifaximin will be either temporarily held or switched to another non-antibiotic therapy (e.g. lactulose or sodium benzoate) during the treatment phase of the trial. Potential subjects in whom the treating hepatologist deem it unsafe to pause or switch from Rifaximin therapy during the 7-10 day treatment phase will be excluded from the study.
• Patients who are currently admitted to the intensive care unit for vasoactive support or mechanical ventilation.
• Patients meeting the North American Consortia for Study of End Stage Liver Disease (NACSELD) criteria for acute-on-chronic liver failure (ACLF) with ≥ 2 organ failures by NACSELD-ACLF criteria at time of enrollment.
• Patients with known intestinal barrier dysfunction, including active GI bleeding, enteropathy (including celiac disease), clinically active inflammatory bowel disease (Crohn's or Ulcerative Colitis), ischemic colitis, microscopic colitis, graft versus host disease (GVHD), or gastrointestinal malignancy.
• o Active inflammatory bowel disease (IBD) will be defined based on a combination of:
• Symptoms (diarrhea and/or abdominal pain without another explanation)
• Laboratory evidence of inflammation (e.g. elevated CRP or fecal calprotectin without another explanation); and
• Either radiologic, endoscopic, and/or histologic evidence of active IBD.
• If IBD is suspected, this will be investigated with the general GI consult service prior to approaching for enrollment.
• If patients carry a diagnosis of IBD but do not meet the above criteria, they will be eligible for enrollment unless their IBD is managed with a systemic immunosuppression medication (e.g. anti-TNF-alpha therapy).
• If any form of the above intestinal disorders is suspected, they will be investigated with the general GI consult service prior to approaching for enrollment.
• Profoundly immunocompromised patients, including patients with primary immunodeficiency, solid organ transplant recipients, any history of hematopoietic stem cell transplant (HSCT), ongoing cancer treatment, neutropenia < 500 cells/mm3, HIV untreated or with CD4 < 200 cells/mm3, immunosuppressive medications, including rituximab, anti-cytokine therapy, anti-rejection medications, chronic corticosteroids (a dose ≥ 20mg of prednisone daily for ≥ 1 month), biologic therapy for autoimmune condition.
• Patients with delayed gastrointestinal motility as evidenced by ≤ 2 bowel movements per week at the time of enrollment.
• Patients who are allergic to both ampicillin/sulbactam and meropenem.
• These are the two empiric antibiotic therapies that every strain is susceptible to.
• If a patient is allergic to only one of these medications, they may still be approached for enrollment.
• A history of allergy to any of the investigational products/components.
• Patients with liver disease from Hepatitis C.
• Patients with existing inflammatory arthritis.
• History of total colectomy.
• Patients who do not intend to continue their care on a routine basis at the University of Chicago beyond 6 months from the time of enrollment.
• Patients with untreated psychiatric conditions, including illicit substance use disorders, that may interfere with reliable follow-up.

Where it is running

• The University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.