The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06871111
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cirrhosis, Liver
  • Liver Diseases
  • Liver Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Commensal Bacteria Strains — BIOLOGICAL
    7 doses containing 7 capsules will be administered over 7-10 days

Study Details

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 Dates

Start date
Aug 4, 2025
Status verified
Aug 2025
Primary completion
Aug 4, 2027
Completion
Feb 4, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Commensal Consortium A
    Stage 1: 1st 8 patients enrolled will receive Consortium A. This consortium contains 7 different organisms.
  • Experimental: Commensal Consortium B1
    Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 7 different organisms.
  • Experimental: Commensal Consortium B2
    Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 7 different organisms.
  • Experimental: Commensal Consortium C1
    Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 7 different organisms.
  • Experimental: Commensal Consortium C2
    Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 7 different organisms.
  • Experimental: Commensal Consortium D1
    Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 7 different organisms.
  • Experimental: Commensal Consortium D2
    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.
  • Experimental: Commensal Consortium E1
    Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 7 different organisms.
  • Experimental: Commensal Consortium E2
    Stage 2: Based on fecal metagenomic and metabolomic data from Stage 1, subjects may be assigned to this Commensal Consortium. This consortium contains 7 different organisms.

Primary Outcome Measure

The incidence of adverse events (AEs and SAEs) attributable to the Commensal Consortia [ Time Frame: Day 1- Month 12 ]

Central Contacts

  • Matthew A Odenwald, MD, PhD
    773-702-6331
    [email protected]
  • Christopher Lehmann, MD
    773.834.6015

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Chicago Medical CenterChicagoIllinois60637
Matthew Odenwald
[email protected]
Matthew Odenwald, MD, PhD (PRINCIPAL_INVESTIGATOR)
Eric Pamer, MD (PRINCIPAL_INVESTIGATOR)
Christopher Lehmann, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Chicago Medical Center· Chicago, IL

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