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NCT05835206 · ClinicalTrials.gov registry record · Phase 2
Further MT for Antibiotic-Resistant Bacterial Colonization in Inpatients
A Phase 2 study of Multi-drug Resistant Organism, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 5
- Study locations
NCT05835206: Recruiting Phase 2 study of Multi-drug Resistant Organism, sponsored by Emory University.
NCT05835206 is a Phase 2 study of Multi-drug Resistant Organism that is actively recruiting participants, run by Emory University. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05835206, a Phase 2 study of Multi-drug Resistant Organism, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to better understand the effectiveness and safety of microbiome therapies (MT) as a treatment for patients with Multidrug Resistant Organism (MDRO) colonization after an infection. Limited data from prior studies suggest that MT may be an effective treatment to reduce intestinal MDRO colonization Although shedding of MDROs from patients to their surrounding environment is a recognized pathway of transmission, the potential effect of MT on the transmission of MDRO to other patients in the hospital environment is unclear. This study will test the safety and efficacy of MT for this use in hospitalized patients. This study will also help design larger studies. The MT may help reduce MDROs that colonize the gut. By reducing colonization before infections happen, this could help doctors avoid using "last resort" antibiotics that can have serious side effects like kidney damage. The reduction in MDROs after MT was originally identified in patients treated with MT for recurrent Clostridioides difficile (often called "C. diff") diarrhea. It has been shown that a type of MT called fecal microbiota transplant (FMT) can eliminate both C. difficile and other resistant bacteria.
Primary Outcome
MDRO colony-forming unit (CFU) densities from quantitative stool cultures in placebo vs IP-treated participants.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Microbiome Therapeutic
Study Locations (5)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory Rehabilitation Hospital - Atlanta
- Emory University Clinical Research Network - Atlanta
- Emory University Hospital (EUH) - Atlanta
- Emory University at Wesley Woods Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-04-25 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 2 |
What NCT05835206 shows while recruiting
NCT05835206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Multi-drug Resistant Organism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05835206 lists 5 locations in 1 state (Georgia).
Frequently Asked Questions
What is clinical trial NCT05835206 about?
NCT05835206 is a clinical study titled "Further MT for Antibiotic-Resistant Bacterial Colonization in Inpatients". The purpose of this study is to better understand the effectiveness and safety of microbiome therapies (MT) as a treatment for patients with Multidrug Resistant Organism (MDRO) colonization after an infection. Limited data from prior studies suggest that MT may be an effective treatment to reduce in...
What is the current status of trial NCT05835206?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-04-25. Estimated completion is 2026-07-30.
What conditions does trial NCT05835206 study?
This clinical trial studies the following conditions: Multi-drug Resistant Organism.
What interventions are being tested in trial NCT05835206?
The interventions under investigation include: Placebo (DRUG), Microbiome Therapeutic (DRUG).
Who is sponsoring clinical trial NCT05835206?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05835206 being conducted?
This trial has 5 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05835206's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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