NCT05835206 · Emory University
Further MT for Antibiotic-Resistant Bacterial Colonization in Inpatients
(FAIR)
What this study 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.
View original scientific description
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.
Interventions
DRUG
Microbiome Therapeutic
Participants will receive a single course of study treatment (IP, Encapsulated Microbiota): Orally delivered, non-frozen, encapsulated investigational intestinal microbiota, consisting of 16 capsules. One dose (8 capsules) is administered daily (QD) for 2 days. The capsules are to be taken orally with water on an empty stomach. Each dose will be taken approximately every 24 hours, with a minimum of 12 hours from the previous dose to a maximum of 36 hours. Both doses must be completed within the stated 36 hours ±12 hours. Depending on the time of the first dose, dosing may occur over 3 calendar days. A second cycle will begin, and a second treatment will be given if the participant is still MDRO positive on Day 14 of Cycle 1. If applicable, Cycle 2 will begin within 7 days of Day 14.
DRUG
Placebo
Participants will receive a single course of study treatment (Color-matched placebo capsules containing microcrystalline cellulose (MCC) powder), consisting of 16 capsules. One dose (8 capsules) is administered daily (QD) for 2 days. The capsules are to be taken orally with water on an empty stomach. Each dose will be taken approximately every 24 hours, with a minimum of 12 hours from the previous dose to a maximum of 36 hours. Both doses must be completed within the stated 36 hours ±12 hours. Depending on the time of the first dose, dosing may occur over 3 calendar days. A second cycle will begin, and a second treatment will be given if the participant is still MDRO positive on Day 14 of Cycle 1. If applicable, Cycle 2 will begin within 7 days of Day 14.
Primary outcome measures
Change in stool MDRO colony-forming unit (CFU) density
Time frame: Day 0, day 14 of last cycle (each cycle is 14 days), and 28 weeks
MDRO colony-forming unit (CFU) densities from quantitative stool cultures in placebo vs IP-treated participants.
Change in proportion of MDRO colonized participants after last treatment cycle with the investigational product (IP)
Time frame: Day 0, day 14 of last cycle (each cycle is 14 days), and 28 weeks
Proportion of stool cultures positive for any target MDRO will be compared in IP-treated vs placebo-treated participants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Be able to (or have an available Legally Authorized Representative who is able to) understand and be willing to sign a written informed consent document.
- Be at least 18 years old at the time of consent.
- Be able and willing to comply with all study protocol requirements, including the ability to swallow capsules.
- Be colonized with a target MDRO (CRE, VRE, ESBL, MDR Acinetobacter, and/or MDR Pseudomonas) as detected by bacterial culture of stool or perianal/rectal swab.
- Be able and willing to discontinue systemic antibiotics at least one day prior to study Day 0 and for as long as medically able to do so throughout the study.
- Be willing to discontinue probiotics or other microbiota restoration therapies at least one day prior to study Day 0 and for the duration of study participation.
- The effects of the IP on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception
Where
- Atlanta, Georgia
- Johns Creek, Georgia
Collaborators
Centers for Disease Control and Prevention
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations