Multi-Drug Resistant Organism ColonizationPhase 2NCT06321536
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
A Phase 2 study testing Allogeneic Microbiota in Glycerol (9%) (AMG) in people with Multi-Drug Resistant Organism Colonization, run by Emory University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-Drug Resistant Organism Colonization
- What is being tested?
- Allogeneic Microbiota in Glycerol (9%) (AMG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Jan 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 23Show fewer
- Toxic megacolon
- Ileus
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Woodworth, MD contact
United States4 sites, 4 recruiting
- Recruiting
A.G Rhodes Wesley Woods
Atlanta, Georgia, 30329
Michael Woodworth, MD, 404-234-8452, Michael.holmes.woodworth@emory.edu
- Recruiting
Emory Long Term Acute Care (LTAC)
Decatur, Georgia, 30030
Michael Woodworth, MD, 404-234-8452, Michael.holmes.woodworth@emory.edu
- Recruiting
RML Specialty Hospital
Hinsdale, Illinois, 60521
Rachel Madernach, MD, 312-947-2426, rachel_l_medernach@rush.edu
- Recruiting
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
Brendan Kelly, MD, 215-316-5151, brendank@pennmedicine.upenn.edu
About this study
Official title: Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy
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.
Read the detailed description
REACT is a phase two, open-label, randomized, controlled trial of microbiota therapy (MT) to reduce colonization with multi-drug resistant organisms (MDRO) in patients admitted to long-term care facilities. REACT is designed to test the safety and efficacy of instillation of donor intestinal microbiota.
Patients admitted to long-term care facilities (e.g. long-term acute care hospitals and ventilator-capable skilled nursing facilities) found to be MDRO colonized during prevalence screening activities performed in the related APPS study.
Facilities undergo prevalence sampling that involves participant peri-rectal, inguinal, and stool sampling to estimate the prevalence of targeted MDROs (CRE, ESBL, VRE, MDRP) under the accompanying APPS protocol. Patients who are positive with at least one targeted MDRO are eligible for an Emory manufactured MT product (via rectal enema or feeding tube), or observation followed by repeat sampling at Days 7, 14, 21, and 28. Participants will be followed with collection of data on adverse events/safety/changes in medications at Days 0, 7, 14, 21, 28, and followed up once a month for 6 months, after MT administration.
- Being tested
- Allogeneic Microbiota in Glycerol (9%) (AMG)
- Keywords
- Multi-Drug Resistant Organism, Fecal Microbiota Transplant, Antibiotic Resistance, Long-Term Care Facilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Microbiota in Glycerol (9%) (AMG)Drug
Also called Fecal Microbiota Transplant (FMT), Microbiome therapeutic (MT), Stool from healthy donors in saline suspension with 9% glycerol by volume
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: microbiota therapy (MT) | Experimental | Group 1 will offer Microbiome therapeutic (MT) to all MDRO-positive patients (i.e., intervention condition). Receives: Drug: Allogeneic Microbiota in Glycerol (9%) (AMG) |
| Group 2: Observation | No intervention | Group 2 will be assigned to observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in number of solicited Adverse Events (AEs)
Difference in number of solicited AEs between Day 0 and Day 7 in AMG-treated vs Observation participants.
Measured: Day 0, Day 7 post-intervention
Difference in severity of solicited AEs
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.
Measured: Day 0, Day 7 post-intervention
Difference in number of unsolicited AEs
Difference in number of unsolicited AEs between Day 0 and Day 28 in AMG-treated vs Observation participants.
Measured: Day 0, Day 28 post-intervention
Difference in severity of unsolicited AEs
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
Measured: Day 0 and Day 28
Difference in proportion of participant stool positive cultures for any target MDRO among AMG-treated compared to Observation participants
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
Measured: Day 28 post-intervention
Secondary outcomes (3)
Count of serious AEs (SAEs)
Count of serious AEs (SAEs) between Day 0 and Month 6 (Day 180) censored by last telephone visits or death, whichever is later.
Measured: Day 180
Count of AEs of Special Interest (AESIs)
Count of AEs of Special Interest (AESIs) at day Day 180, censored by last telephone visit or death, whichever is later.
Measured: Day 180
Proportion of stool cultures at Day 28 positive for category-specific MDROs
Proportion of stool cultures at Day 28 positive for category-specific MDROs (e.g. ESBL, CRE, MDRP, VRE).
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start13 Jan 2025
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-Drug Resistant Organism ColonizationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Michael Woodworth, Emory University
- Investigators
- Michael Woodworth, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321536
- Sponsor's protocol ID
- STUDY00007230
- Other IDs
- U54CK000601
- Status last verified
- Nov 2025
- First submitted
- 13 Mar 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant solicited adverse event and serious adverse event data will be shared. Isolate genomic data and participant metagenomic data will be shared in public repositories (NCBI) at time of publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy
- ClinicalTrials.gov ID
- NCT06321536
- Acronym / sponsor ID
- STUDY00007230
- Keywords
- Multi-Drug Resistant Organism, Fecal Microbiota Transplant, Antibiotic Resistance, Long-Term Care Facilities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
REACT is a phase two, open-label, randomized, controlled trial of microbiota therapy (MT) to reduce colonization with multi-drug resistant organisms (MDRO) in patients admitted to long-term care facilities. REACT is designed to test the safety and efficacy of instillation of donor intestinal microbiota.
Patients admitted to long-term care facilities (e.g. long-term acute care hospitals and ventilator-capable skilled nursing facilities) found to be MDRO colonized during prevalence screening activities performed in the related APPS study.
Facilities undergo prevalence sampling that involves participant peri-rectal, inguinal, and stool sampling to estimate the prevalence of targeted MDROs (CRE, ESBL, VRE, MDRP) under the accompanying APPS protocol. Patients who are positive with at least one targeted MDRO are eligible for an Emory manufactured MT product (via rectal enema or feeding tube), or observation followed by repeat sampling at Days 7, 14, 21, and 28. Participants will be followed with collection of data on adverse events/safety/changes in medications at Days 0, 7, 14, 21, 28, and followed up once a month for 6 months, after MT administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: microbiota therapy (MT) | Experimental | Drug: Allogeneic Microbiota in Glycerol (9%) (AMG)Group 1 will offer Microbiome therapeutic (MT) to all MDRO-positive patients (i.e., intervention condition). |
| Group 2: Observation | No intervention | –Group 2 will be assigned to observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (23 listed)
- 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):
- 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:
- Have a history of significant food allergy that led to anaphylaxis or hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Microbiota in Glycerol (9%) (AMG)Also: Fecal Microbiota Transplant (FMT), Microbiome therapeutic (MT), Stool from healthy donors in saline suspension with 9% glycerol by volumeParticipants 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. | Drug | Group 1: microbiota therapy (MT) |
Primary outcome
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
3 secondary outcomes
Count of serious AEs (SAEs)
Time frame: Day 180
Count of AEs of Special Interest (AESIs)
Time frame: Day 180
Proportion of stool cultures at Day 28 positive for category-specific MDROs
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: Yes. Deidentified participant solicited adverse event and serious adverse event data will be shared. Isolate genomic data and participant metagenomic data will be shared in public repositories (NCBI) at time of publication
Related trials for Multi-Drug Resistant Organism Colonization
RecruitingPhase 2
Further MT for Antibiotic-Resistant Bacterial Colonization
Intestinal Multi-drug Resistant Organism Colonization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Woodworth, MD contact
Michael Woodworth, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Microbiota in Glycerol (9%) (AMG) in people with Multi-Drug Resistant Organism Colonization, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepti Suchindran, PhD (404-727-9193, deepti.rao.suchindran@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in number of solicited Adverse Events (AEs) (time frame: Day 0, Day 7 post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.