Recruiting
Phase 2

Microbiota Therapy

Sponsor:

Emory University

Code:

NCT06321536

Conditions

Multi-Drug Resistant Organism Colonization

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Allogeneic Microbiota in Glycerol (9%) (AMG)

Study Details

Brief summary:

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.

Conditions

Multi-Drug Resistant Organism Colonization

Study ID

NCT06321536

Start date

Jan 13, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Be able (or have available a Legal Authorized Representative who is able) to understand and sign a written informed consent document.
2. Be at least 18 years old at the time of consent.
3. Be able to comply with all study protocol requirements, including able to receive MT as retention enema or via enteral feeding tube and be available for the duration of the study follow up.
4. Be colonized with a target MDRO (CRE, VRE, ESBL, MDR Pseudomonas) as detected by bacterial culture of stool or peri-rectal swab (collected in companion APPS facility prevalence sampling protocol).
5. Be able to discontinue or complete planned courses of antibiotics, probiotics, and other microbiota restoration therapies by Day -1 and not resume until after Day 28.
6. The effects of the MT on the developing human fetus are unknown. For this reason, persons of child-bearing potential (POCBP) 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.
7. Agree to refrain from receptive anal intercourse until the last biological specimen (stool sample or peri-rectal swab) is collected (Day 28).

Exclusion Criteria:

1. Are pregnant, breastfeeding, lactating, or planning a pregnancy during study duration (through 4 weeks after the last dose of investigational product, or MT), if POCBP.
2. Have known uncontrolled intercurrent illness(es):

1. Symptomatic congestive heart failure
2. Acute coronary syndrome
3. Cardiac arrhythmia
4. Untreated in-situ colorectal cancer
5. Toxic megacolon
6. Ileus
7. Positive stool studies without completion of treatment course (including ova and parasites, Salmonella spp, Shigella, Campylobacter, and other enteropathogens).
8. other acute illness that in the opinion of the investigator could affect the safety of the participant or make study data uninterpretable.
3. Are on systemic antibiotics for any reason other than treatment of recent MDRO infection or clear anticipated need for antibiotics during the follow up period that cannot be rescheduled (e.g. fluoroquinolone prophylaxis for percutaneous nephrostomy tube exchange, prolonged antibiotic course for endocarditis). Participants must complete the planned antibiotic course by study Day -1.
4. Have a compromised immune system, defined as:

1. AIDS with CD4+ T-cell count <200 and detectable HIV viral load on most recent assay.
2. Absolute neutrophil count (ANC) <1,000 neutrophils / mL on day of enrollment.
3. Active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment within 2 months prior to enrollment.
4. History of hematopoietic cell transplantation, either allogeneic or autologous in the last 1 year.
5. Have a history of significant food allergy that led to anaphylaxis or hospitalization.
6. Have a life expectancy of 24 weeks or less
7. 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:

1. Known active intravenous drug or alcohol abuse
2. Uncontrolled psychiatric illness
3. Social situations (e.g. incarceration)
8. Received an interventional agent (drug, device, or procedure) within 28 days prior to enrollment.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group 1: microbiota therapy (MT)

Group 1 will offer Microbiome therapeutic (MT) to all MDRO-positive patients (i.e., intervention condition).

no intervention: Group 2: Observation

Group 2 will be assigned to observation.

Interventions

Allogeneic Microbiota in Glycerol (9%) (AMG)

Participants will receive an Emory-manufactured MT product, delivered as 250mL via rectal enema or 30mL instillation via an existing functioning feeding tube with the rate adjusted to participant tolerance. Participants will receive three doses over the first seven days of the study.

Primary outcome measure

  • Difference in number of solicited Adverse Events (AEs) [ Time Frame: Day 0, Day 7 post-intervention ]
  • Difference in severity of solicited AEs [ Time Frame: Day 0, Day 7 post-intervention ]
  • Difference in number of unsolicited AEs [ Time Frame: Day 0, Day 28 post-intervention ]
  • Difference in severity of unsolicited AEs [ Time Frame: Day 0 and Day 28 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

A.G Rhodes Wesley Woods

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Emory Long Term Acute Care (LTAC)

Recruiting

Decatur, Georgia, United States, 30030

Contacts

RML Specialty Hospital

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

Penn Medicine Rittenhouse

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

More Information

Sponsor

Emory University

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

  • Multi-Drug Resistant Organism
  • Fecal Microbiota Transplant
  • Antibiotic Resistance
  • Long-Term Care Facilities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Emory University on 2025-11-05.