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RECRUITING
NCT06321536
PHASE2

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

Sponsor: Emory University

View on ClinicalTrials.gov

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.

Official title: Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-01-13

Completion Date

2026-12

Last Updated

2025-11-05

Healthy Volunteers

No

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.

Locations (4)

A.G Rhodes Wesley Woods

Atlanta, Georgia, United States

Emory Long Term Acute Care (LTAC)

Decatur, Georgia, United States

RML Specialty Hospital

Hinsdale, Illinois, United States

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, United States