Fecal Microbiota Transplantation (FMT) for MDRO UTI (NCT03367910) | Clinical Trial Compass
CompletedPhase 1/2
Fecal Microbiota Transplantation (FMT) for MDRO UTI
United States1 participantsStarted 2018-02-08
Plain-language summary
The purpose of this study is to determine the safety and impact of fecal microbiota transplantation (FMT) on the fecal and urine microbiome, urine metabolome, risk of recurrent urinary tract infection (UTI), and persistent multidrug resistant organism (MDRO) colonization of patients with a history of recurrent MDRO UTIs. This is an open label phase 1-2 study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years old.
* Outpatient status at time of FMT.
* History of at least three recurrent UTIs due to an MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or at least two recurrent infections due to MDRO for which only antimicrobials with rate limiting toxicities (see above) are available.
* Be without active infection due to the MDRO at the time of FMT.
* Not be receiving antimicrobials (therapeutic or suppressive) within 48 hours of FMT.
Exclusion Criteria:
* Age \<18 years
* Inpatient status at time of FMT
* Ineligible UTI
* \>1 organism in urine (other than minimal contaminants)
* Decline to participate
* Recurrent Clostridium difficile infection
* Presence of intra-abdominal devises
* Neutropenia (ANC \<500 mm3)
* Intestinal mucosal disruption
* Unlikely to survive 6 months
* Pregnancy or unwillingness to use contraceptives
* Short gut syndrome
* Use of medications that affect intestinal motility
* Gastrointestinal motility disorder
* Inflammatory bowel disease
* Recent abdominal surgery
* Active typhlitis
* Active diverticulitis
* Current gastrointestinal graft versus host disease
* HIV with lack of antiretroviral therapy (ART)
* CD4 count \<200 mm3
* Peritoneal dialysis
* Cirrhosis with ascites
* Active intra-abdominal malignancy
* Presence of chronic indwelling foley catheter, chronic suprapubic catheter, or ileal conduit
* Active hepatitis C
* Active hepatitis B
* Presence of ureteral stent
* Active kid…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Adverse Events During and After FMT