Actively Recruiting
Further MT for Antibiotic-Resistant Bacterial Colonization
Led by Emory University · Updated on 2026-05-06
40
Participants Needed
6
Research Sites
174 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
C
Centers for Disease Control and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Further MT for Antibiotic-Resistant Bacterial Colonization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent (or have a Legally Authorized Representative who can)
- At least 18 years old at consent
- Able and willing to follow study requirements, including swallowing capsules
- Colonized with target MDRO (CRE, VRE, ESBL, MDR Acinetobacter, and/or MDR Pseudomonas) confirmed by stool or perianal/rectal swab culture
- Able and willing to stop systemic antibiotics at least one day before study start and as medically allowed during study
- Willing to stop probiotics or other microbiota therapies at least one day before study start and during participation
- Women of childbearing potential and men must agree to use effective contraception during the study
You will not qualify if you...
- Pregnant, breastfeeding, lactating, or planning pregnancy during study period (including 4 weeks after last study dose), if woman of childbearing potential
- Have uncontrolled illnesses such as symptomatic congestive heart failure, acute coronary syndrome, cardiac arrhythmia, untreated colorectal cancer, toxic megacolon or ileus, or medications that reduce GI motility increasing aspiration risk
- Recent positive stool studies for parasites or other enteropathogens (other than MDROs) within last 30 days
- Any other acute illness that would prevent study entry per investigator
- Taking systemic antibiotics except if for recent MDRO infection and able to complete antibiotics by study Day -1
- Immunocompromised conditions including AIDS with CD4 count <200, recent low neutrophil counts, active cancer treatment within 2 months, or recent hematopoietic cell transplantation within 1 year
- History of severe food allergy causing anaphylaxis or hospitalization
- Life expectancy of 24 weeks or less
- Conditions interfering with study compliance or objectives such as active intravenous drug/alcohol abuse, psychiatric illness, or social issues
- Participation in another interventional MDRO study within last 28 days
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory Rehabilitation Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Emory University Clinical Research Network
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Emory University Hospital (EUH)
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Emory University at Wesley Woods Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
6
Emory Johns Creek Hospital
Johns Creek, Georgia, United States, 30097
Actively Recruiting
Research Team
M
Michael Woodworth, MD, MSc
CONTACT
E
Ella Wetzel, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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