Gut bacteria therapy takes on superbugs in new trial
NCT ID NCT06321536
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a special mix of gut bacteria (microbiota therapy) can safely reduce the amount of drug-resistant germs living in the gut. About 60 adults who carry these superbugs will either receive the treatment or be observed. The goal is to see if the therapy can clear the resistant bacteria without causing serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multi-drug resistant organism colonization are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
A.G Rhodes Wesley Woods
RECRUITINGAtlanta, Georgia, 30329, United States
-
Emory Long Term Acute Care (LTAC)
RECRUITINGDecatur, Georgia, 30030, United States
-
Penn Medicine Rittenhouse
RECRUITINGPhiladelphia, Pennsylvania, 19146, United States
-
RML Specialty Hospital
RECRUITINGHinsdale, Illinois, 60521, United States