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New treatment option for Liver Diseases
Official title The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial
ClinicalTrials.gov ID: NCT06871111
What this study is testing
What is Commensal Bacteria Strains?
Commensal Bacteria Strains is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for liver diseases.
Also referred to as Lyophilized live commensal bacterial strains (Live Biotherapeutic Product), Commensal Consortium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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...
- 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...
- Patients with known intestinal barrier dysfunction, including active GI bleeding, enteropathy (including celiac disease), clinically active...
See the full eligibility 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. 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
- 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...
- 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...
- 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...
- 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.
- Unable to participate based on medical judgement of the care team.
- Special populations:
- Women of childbearing age will have a:
- Negative serum pregnancy test at screening
- Use a medically acceptable and highly effective method of birth control for at least 6 weeks following completion of treatment.
- Another investigational drug or LBP:
- Prior use will be permitted;
- Concurrent use will preclude enrollment;
- Use will be restricted for the duration of the study (12 months after commensal consortia completion)
- Patients who are prescribed ACE-inhibitors and receive a consortium containing C. comes will receive more frequent blood pressure monitoring.
- Patients who are prescribed metformin will require either:
- Switch to another medication for diabetes control; or
- More frequent Vitamin B12 monitoring at 1, 3, 6, and 12 months of enrollment.
- If a Vitamin B12 deficiency is discovered, it will be repleted as clinically indicated.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.