Status:
COMPLETED
Fecal Microbiota Transplantation (FMT) for MDRO UTI
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Centers for Disease Control and Prevention
University of Pennsylvania
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Multidrug resistant organism (MDRO) infections are increasingly common. The most common type of infection caused by MDROs is urinary tract infections (UTIs). Many MDROs are inhabitants of the colon, a...
Eligibility Criteria
Inclusion
- 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
- 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 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
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03367910
Start Date
February 8 2018
End Date
December 31 2021
Last Update
March 18 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University
St Louis, Missouri, United States, 63110