Phase 2
N=1
Fecal Microbiota Transplantation (FMT) for MDRO UTI
Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT03367910 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Number of Patients With Adverse Events During and After FMT — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fecal microbiota transplant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events During and After FMT |
1 | — |
| SECONDARY Number of Patients With Recurrent UTI Post-FMT |
1 | — |
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.
Eligibility Criteria
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 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 kidney stone that is believed to be a persistent source of bacterial colonization
- Any condition where the investigator feels the risks of FMT outweigh the benefits
Data sourced from ClinicalTrials.gov (NCT03367910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.