Commensal Bacteria for Liver Disease
(MARCO Trial)

Overseen ByChristopher Lehmann, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Chicago

Must not be taking: Antibiotics, Immunosuppressants

Disqualifiers: ICU admission, Intestinal dysfunction, Immunocompromised, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but some changes might be required. If you are taking rifaximin, it may be temporarily held or switched during the trial. If you are on metformin, you might need to switch medications or have more frequent Vitamin B12 monitoring.

What data supports the effectiveness of the treatment Commensal Bacteria Strains for liver disease?

Research shows that certain gut bacteria, like Faecalibacterium prausnitzii and Bacteroides acidifaciens, may help protect against liver damage by improving gut health and reducing harmful liver processes. These findings suggest that using specific bacteria strains could be beneficial in treating liver diseases.¹ ² ³ ⁴ ⁵

Is there any safety data on the use of commensal bacteria for liver disease?

The research articles do not provide specific safety data on the use of commensal bacteria for liver disease. They discuss the role of gut bacteria in liver conditions but do not address the safety of using these bacteria as a treatment.¹ ³ ⁶ ⁷ ⁸

How does the treatment with Commensal Bacteria Strains differ from other treatments for liver disease?

This treatment is unique because it uses specific strains of beneficial bacteria, like Faecalibacterium prausnitzii, to potentially improve liver health by altering the gut microbiome, which is different from traditional treatments that may not target the gut-liver connection.¹ ⁹ ¹⁰ ¹¹ ¹²

Eligibility Criteria

The MARCO trial is for hospitalized patients with complications from liver diseases like cirrhosis or diabetic liver disease, who also have low levels of certain fecal metabolites. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

MELD score ≤ 30 at time of enrollment

Subject has specific levels of butyrate and deoxycholate in fecal sample

I have been diagnosed with liver disease or cirrhosis.

See 3 more

Exclusion Criteria

Patients with known intestinal barrier dysfunction including specific conditions

Profoundly immunocompromised patients with specific conditions

MELD score >30 at time of enrollment

See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

8 patients receive 7 doses of the same combination of bacterial strains and are monitored for safety and tolerability

7 doses

In-person visits for each dose

Adaptive Treatment

16 additional subjects are randomized to one of two additional consortia based on safety and metabolite production from the initial phase

12 months

Regular in-person and virtual follow-ups

Follow-up

Participants are monitored for safety, tolerability, and metabolite production for 12 months

12 months

In-person contact, telephone calls, and/or Patient-Reported Outcomes

Treatment Details

Interventions

Commensal Bacteria Strains

Trial Overview This study tests the safety and tolerability of administering one out of nine novel live Commensal Consortia, each containing eight bacterial strains from healthy donors, to see if they can help patients with liver disease.

Participant Groups

9Treatment groups

Experimental Treatment

Group I: Commensal Consortium E2Experimental Treatment1 Intervention