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Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a special mix of bacteria from healthy individuals to aid those with liver disease. It aims to determine if these commensal bacteria strains can be safely administered to patients hospitalized with liver issues. Participants will receive one of several bacterial combinations to identify the safest and most tolerable option. Individuals currently hospitalized with liver disease and low levels of certain gut chemicals might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that good bacteria from healthy people, known as commensal bacteria, offer safety and benefits. These bacteria help maintain gut balance and combat harmful bacteria. One study tested a similar group of bacteria on patients with ulcerative colitis, a type of bowel disease, and found them to be generally safe and well-tolerated.

Another study explored their potential benefits for other health issues, such as certain cancers, and suggested they are safe to use.

This trial is in an early phase, focusing on the safety of these bacteria for people with liver disease complications. Early studies suggest these commensal bacteria are well-tolerated, but further research is needed to confirm this.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they use commensal bacteria strains to tackle liver disease in a completely new way. Unlike current medications that often target symptoms or specific liver functions, these treatments harness beneficial bacteria to potentially restore balance in the gut microbiome. This approach could improve liver health by addressing underlying causes related to gut-liver interactions. Additionally, the use of fecal metagenomic and metabolomic data to tailor treatments is cutting-edge, offering a personalized approach that might enhance effectiveness and reduce side effects compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for liver disease?

Studies have shown that gut bacteria play a crucial role in liver health. Changes in these bacteria are linked to liver disease. Research suggests that correcting this imbalance might aid in addressing liver problems. In this trial, participants will receive various combinations of friendly bacteria from healthy individuals, known as commensal bacteria, to help restore balance. Early findings indicate that these bacteria might improve liver health by addressing gut-liver interactions. Although still in the early stages, these bacteria show promise in supporting liver health.⁶ ⁷ ⁸ ⁹ ¹⁰

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

9Treatment groups

Experimental Treatment

Group I: Commensal Consortium E2Experimental Treatment1 Intervention