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NCT06321536
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy
Phase 2 trial testing Allogeneic Microbiota in Glycerol (9%) (AMG) in Multi-Drug Resistant Organism Colonization in 60 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 13 January 2025 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Allogeneic Microbiota in Glycerol (9%) (AMG) — full drug profile →
Conditions studied
- Multi-Drug Resistant Organism Colonization — all drugs for Multi-Drug Resistant Organism Colonization →
Sponsor
Emory University
Who can join
18 and older, any sex, with Multi-Drug Resistant Organism Colonization. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Difference in number of solicited Adverse Events (AEs)
Time frame: Day 0, Day 7 post-intervention
Difference in number of solicited AEs between Day 0 and Day 7 in AMG-treated vs Observation participants. -
Difference in severity of solicited AEs
Time frame: Day 0, Day 7 post-intervention
Difference in severity of solicited AEs will be compared in AMG-treated vs Observation participants. Graded as mild, moderate or severe, up to 7 days post-intervention. -
Difference in number of unsolicited AEs
Time frame: Day 0, Day 28 post-intervention
Difference in number of unsolicited AEs between Day 0 and Day 28 in AMG-treated vs Observation participants. -
Difference in severity of unsolicited AEs
Time frame: Day 0 and Day 28
Difference in severity of unsolicited AEs will be collected between Day 0 and Day 28. Graded as mild, moderate or severe and compared in AMG-treated vs Observation participants -
Difference in proportion of participant stool positive cultures for any target MDRO among AMG-treated compared to Observation participants
Time frame: Day 28 post-intervention
Difference in proportion of participant stool cultures at Day 28 positive will be measured for any target MDRO among AMG-treated compared to Observation participants
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06321536
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06321536 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Emory University
- Last refreshed: 4 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06321536.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing