Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation

NCT06214403 | Withdrawn Phase 2 DMC

• 1 other identifier: 23-5419
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

ARO-DECAMP is a multi-centre, placebo-controlled, pilot and feasibility randomized controlled trial for the microbial consortium Microbial Ecosystem Therapeutic-2. Non-intensive care unit patients ≥ 18 years old diagnosed with a bloodstream infection and receiving treatment for an antibiotic resistant organism will be included. Participants will be randomized to receive either MET-2 or placebo for 10 days. Recruitment rate and study intervention adherence will be evaluated for feasibility. Participants will be followed for 180 days, and biological samples will be collected periodically for clinical, ecological, and biomarker outcomes.

Conditions

Gram-negative Bacteremia; Microbial Colonization; Antibiotic Resistant Infection

Keywords

Microbial consortia; Microbiome; Decolonization; Infection; Bacteremia; Antibiotic; Microbiota; Antibiotic resistance

Outcome Measures

Primary Outcomes (2)

• Recruitment rate overall and by study site

  Defined by the numbers of eligible, consented, and randomized patients

  1.5 years

• Adherence to MET-2/placebo for the treatment duration

  Defined as \>80% of loading dose (16/20 pills) + \>75% of daily doses (18/24 pills) for the maintenance period, as determined by returned unused capsules

  30 days

Secondary Outcomes (3)

• Change in microbiome composition after intervention

  180 days

• Number of biomarker samples collected, by sample type and timepoint

  30 days

• Concentration of potential biomarkers in pre- and post-randomization blood and urine samples

  180 days

Other Outcomes (8)

• Adverse events

  180 days

• 90- and 180-day infection rate

  180 days

• ARO colonization by culture at 30 and 90 days post-intervention

  90 days

Study Arms (2)

MET-2

EXPERIMENTAL

Participants randomized to the intervention will receive MET-2 daily for 10 days. MET-2 capsules are administered orally at 0.5 g per capsule, containing 3.1 x 10\^5-10\^11 colony forming units (CFU). An initial loading dose of 10 MET-2 capsules/day will be taken for 2 days (5 grams total). For the following 8 days, participants will take a maintenance dose of 3 MET-2 capsules/day (1.5 grams total).

Drug: MET-2

Placebo

PLACEBO COMPARATOR

Participants randomized to the placebo will receive microcrystalline cellulose in a capsule, identical in appearance to MET-2 but not containing live bacteria. Participants will take the placebo in the same dosing schedule as the MET-2 arm: 10 capsules daily for 2 days, followed by 3 capsules daily for 8 days.

Drug: Placebo

Interventions

MET-2 DRUG

Microbial Ecosystem Therapeutics (MET) is a defined microbial community derived from healthy donor stool. MET capsules are orally administered mixtures of pure cultures of human-derived bacterial strains.

MET-2

Placebo DRUG

Microcrystalline Cellulose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years old) inpatient not admitted to the ICU or equivalent (step-up and step-down units are eligible)
• Positive blood culture with an ARO:
• AmpC beta-lactamase producing species: Enterobacter cloacae, Citrobacter spp., Klebsiella aerogenes, Serratia spp., Morganella morganii, Hafnia alvei OR
• ESBL-producing gram-negative bacilli
• Currently receiving treatment for the bloodstream infection

You may not qualify if:

• Inability to swallow oral MET-2 or placebo capsule
• Recipient of small bowel transplant
• Inflammatory bowel disease, short bowel syndrome, diverting/non-diverting ileo/colostomy
• Use of \>3 days over-the-counter or prescription probiotics (not including food additives) within 10 days of enrolment
• Receipt of fecal microbiota transplant (FMT) within 3 months of enrolment
• Absolute neutrophil count \<0.5x109/L
• Death expected within 72 hours of enrolment
• Planned continuation of non-prophylaxis antimicrobial therapy active against the bloodstream isolate for \>42 days
• Known pregnancy, planning to become pregnant during the study period, or breastfeeding
• Any other reason in view of the site investigator or treating team

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (4)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 1L7, Canada

Location

Sinai Health

Toronto, Ontario, M6G 1X5, Canada

Location

MeSH Terms

Conditions

Communicable Diseases; Infections; Bacteremia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Bryan Coburn, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 19, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CA (4)