NCT06321536 · Emory University
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
What this study is about
REACT is a phase two, where both patients and doctors know the treatment given, randomly assigned, controlled trial of microbiota therapy (MT) to reduce colonization with multi-drug resistant organisms (MDRO). REACT is designed to assess the safety and effectiveness of MT administered to subjects colonized with a MDRO.
View original scientific description
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.
Interventions
DRUG
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 measures
Difference in number of solicited Adverse Events (AEs)
Time frame: Day 0, Day 7 post-intervention
Difference in number of solicited AEs between Day 0 and Day 7 in AMG-treated vs Observation participants.
Difference in severity of solicited AEs
Time frame: Day 0, Day 7 post-intervention
Difference in severity of solicited AEs will be compared in AMG-treated vs Observation participants. Graded as mild, moderate or severe, up to 7 days post-intervention.
Difference in number of unsolicited AEs
Time frame: Day 0, Day 28 post-intervention
Difference in number of unsolicited AEs between Day 0 and Day 28 in AMG-treated vs Observation participants.
Difference in severity of unsolicited AEs
Time frame: Day 0 and Day 28
Difference in severity of unsolicited AEs will be collected between Day 0 and Day 28. Graded as mild, moderate or severe and compared in AMG-treated vs Observation participants
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
Difference in proportion of participant stool cultures at Day 28 positive will be measured for any target MDRO among AMG-treated compared to Observation 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 (or have available a Legal Authorized Representative who is able) to understand and sign a written informed consent document.
- Be at least 18 years old at the time of consent.
- 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.
- 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).
- 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.
- 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.
- Agree to refrain from receptive anal intercourse until the last biological specimen (stool sample or peri-rectal swab) is collected (Day 28).
Exclusion criteria
- 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.
- Have known uncontrolled intercurrent illness(es):
- Symptomatic congestive heart failure
- Acute coronary syndrome
- Cardiac arrhythmia
- Untreated in-situ colorectal cancer
- Toxic megacolon
- Positive stool studies without completion of treatment course (including ova and parasites, Salmonella spp, Shigella, Campylobacter, and other enteropathogens).
- other acute illness that in the opinion of the investigator could affect the safety of the participant or make study data uninterpretable.
- 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.
- Have a compromised immune system, defined as:
- AIDS with CD4+ T-cell count \<200 and detectable HIV viral load on most recent assay.
- Absolute neutrophil count (ANC) \<1,000 neutrophils / mL on day of enrollment.
- Active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment within 2 months prior to enrollment.
- 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
- Uncontrolled psychiatric illness
- Social situations (e.g. incarceration)
- Received an interventional agent (drug, device, or procedure) within 28 days prior to enrollment.
Where
- Atlanta, Georgia
- Decatur, Georgia
- Hinsdale, Illinois
- Philadelphia, Pennsylvania
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 Nov 5, 2025 · Source of record for eligibility and locations