Commensal Bacteria for Liver Disease
(MARCO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: University of Chicago
No Placebo Group
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.
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 am 18 years old or older.
+4 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
+15 more
Participant Groups
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.
9Treatment groups
Experimental Treatment
Group I: Commensal Consortium E2Experimental Treatment1 Intervention
Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 8 different organisms.
Group II: Commensal Consortium E1Experimental Treatment1 Intervention
Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 8 different organisms.
Group III: Commensal Consortium D2Experimental Treatment1 Intervention
Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 8 different organisms.
Group IV: Commensal Consortium D1Experimental Treatment1 Intervention
Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 8 different organisms.
Group V: Commensal Consortium C2Experimental Treatment1 Intervention
Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 8 different organisms.
Group VI: Commensal Consortium C1Experimental Treatment1 Intervention
Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 8 different organisms.
Group VII: Commensal Consortium B2Experimental Treatment1 Intervention
Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 8 different organisms.
Group VIII: Commensal Consortium B1Experimental Treatment1 Intervention
Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 8 different organisms.
Group IX: Commensal Consortium AExperimental Treatment1 Intervention
Stage 1: 1st 8 patients enrolled will receive Consortium A. This consortium contains 8 different organisms.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Chicago Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor