Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)

Conditions

• Multi-Drug Resistant Organism Colonization

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Allogeneic Microbiota in Glycerol (9%) (AMG) — DRUG
  Participants will receive an Emory-manufactured MT product, delivered as 250mL via rectal enema or 30mL instillation via an existing functioning feeding tube with the rate adjusted to participant tolerance. Participants will receive three doses over the first seven days of the study.

Study Details

REACT is a phase two, open-label, randomized, controlled trial of microbiota therapy (MT) to reduce colonization with multi-drug resistant organisms (MDRO). REACT is designed to assess the safety and efficacy of MT administered to subjects colonized with a MDRO. The overarching hypothesis is that MT can reduce MDRO colonization with safety that is comparable to observation.

Key Dates

Start date

Jan 13, 2025

Status verified

Nov 2025

Primary completion

Jul 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1: microbiota therapy (MT)
  Group 1 will offer Microbiome therapeutic (MT) to all MDRO-positive patients (i.e., intervention condition).
• No Intervention: Group 2: Observation
  Group 2 will be assigned to observation.

Primary Outcome Measure

Difference in number of solicited Adverse Events (AEs) [ Time Frame: Day 0, Day 7 post-intervention ]

Central Contacts

• Deepti Suchindran, PhD
  404-727-9193
  [email protected]
• Michael Woodworth, MD
  [email protected]

Locations (4)

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