Fecal Microbiota Transplantation (FMT) for MDRO UTI



Status:Enrolling by invitation
Conditions:Other Indications, Infectious Disease, Urology, Urinary Tract Infections
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:5/27/2018
Start Date:February 8, 2018
End Date:June 30, 2020

Use our guide to learn which trials are right for you!

Fecal Microbiota Transplantation Using RBX2660 for the Prevention of Recurrent Urinary Tract Infections Due to Multidrug Resistant Organisms

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.

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, and MDROs can contaminate the periurethral area and migrate to the bladder.
Patients with MDRO UTI frequently experience multiple relapses and hospitalizations, which
both increase the individual's morbidity and mortality and leads to additional MDRO
nosocomial spread. There are few options available to prevent MDRO UTIs, and there are
limited strategies to identify patients at risk for recurrent MDRO UTI and prevent or reverse
MDRO colonization. A potential novel method to reverse MDRO colonization and prevent
recurrent UTI would be by repopulating the gut microbiome with "healthy" microbiota by fecal
microbiota transplantation (FMT).

In this study, participants with a history of severe, recurrent MDRO UTI will receive FMT.
Participants will submit stool and urine specimens pre- and post-FMT, and the effect of FMT
on the participants' fecal and urine microbiome, urine metabolome, persistent MDRO
colonization, and risk of recurrent UTI will be evaluated.

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 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
We found this trial at
1
site
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials