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

NCT06321536 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-05

No results posted yet for this study

Summary

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.

Conditions

  • Multi-Drug Resistant Organism Colonization

Interventions

DRUG

Allogeneic Microbiota in Glycerol (9%) (AMG)

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.

Sponsors & Collaborators

Principal Investigators

  • Michael Woodworth, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2026-07-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06321536 on ClinicalTrials.gov