Recruiting
Phase 2

MT

Sponsor:

Emory University

Code:

NCT05835206

Conditions

Intestinal Multi-drug Resistant Organism Colonization

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microbiome Therapeutic

Placebo

Study Details

Brief 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.

Conditions

Intestinal Multi-drug Resistant Organism Colonization

Study ID

NCT05835206

Start date

Apr 25, 2024

Status verified date

May, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

Exclusion Criteria:

  • Be pregnant, breastfeeding, lactating, or planning a pregnancy during the study duration (through 4 weeks after the last dose of investigational product, or IP), if women of childbearing potential (WOCBP).
  • Have known uncontrolled intercurrent illness(es) such as, but not limited to Symptomatic congestive heart failure, acute coronary syndrome, cardiac arrhythmia, untreated in situ colorectal cancer, toxic megacolon or ileus, use of medications that decrease GI motility and increase broncho-aspiration risk (e.g. loperamide, diphenoxylate/atropine, cholestyramine), or history of positive stool studies or cultures in the last 30 days for ova, parasites, Salmonella, Shigella, Campylobacter, or other enteropathogens other than those detected by screening MDRO stool cultures for inclusion.
  • Have any other intercurrent acute illness that in the opinion of the investigator will preclude the subject from entering the study.
  • Be on systemic antibiotics for any reason other than if the MDRO infection was recent or the potential participant is still taking antibiotics for target MDRO at the time of screening. If the latter, the participant must be able (in the opinion of their treating providers) to complete the planned antibiotic course by study Day -1.
  • Have a compromised immune system, defined as AIDS with a cluster of differentiation 4 (CD4)+ T-cell count <200, history of documented absolute neutrophil count (ANC) <1,000 neutrophils/mL within 14 days of D0, active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment within 2 months of enrollment or history of hematopoietic cell transplantation, either allogeneic or autologous in the last 1 year.
  • Have a history of significant food allergy that led to anaphylaxis or hospitalization.
  • Have a life expectancy of 24 weeks or less
  • Have any condition that, in the opinion of the investigator, might interfere with study objectives or limit compliance with study requirements, including but not limited to known active intravenous drug or alcohol abuse, psychiatric illness, and/or social situation
  • Participated in an investigational study that also meets one of the following criteria: Received an interventional agent (drug, device, or procedure) in the last 28 days or enrollment in any other interventional study for MDROs.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: microbiome therapeutic

The study intervention is manufactured from a healthy screened donor as an investigational product (IP) and delivered via swallowed capsule after room reset of the patient's hospital room.

placebo comparator: Placebo

The control arm will remain in routine contact precautions per standard of care, take placebo capsules, and have a room reset.

Interventions

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.

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 measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Michael Woodworth, MD, MSc

404-778-1691mwoodwo@emory.edu

Ella Wetzel, MS

770-946-2109evwetze@emory.edu

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory Rehabilitation Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Emory University Clinical Research Network

Recruiting

Atlanta, Georgia, United States, 30322

Emory University Hospital (EUH)

Recruiting

Atlanta, Georgia, United States, 30322

Emory University at Wesley Woods Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Emory Johns Creek Hospital

Recruiting

Johns Creek, Georgia, United States, 30097

More Information

Sponsor

Emory University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Carbapenem-resistant Enterobacteriaceae (CRE)
  • Vancomycin-Resistant Enterococcus (VRE)
  • Extended Spectrum Beta-Lactamase (ESBL)
  • Multi-Drug Resistant (MDR) Acinetobacter
  • Multi-Drug Resistant (MDR) Pseudomonas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-05-06.