Urinary Tract Infections
Conditions
Keywords
Urinary tract infection, Multidrug resistant organism, Fecal microbiota transplantation
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 (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.
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, 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.
Interventions
DRUGFecal microbiota transplant
150mL of FMT product RBX2660 delivered via enema
Sponsors
Centers for Disease Control and Prevention
University of Pennsylvania
Duke University
Rush University
Rebiotix Inc.
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants with eligible MDRO UTIs will receive FMT.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events During and After FMT | Six months post-FMT | The number, types, severity, and relation of adverse events to study procedures or product will be analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Recurrent UTI Post-FMT | Six months post-FMT | Risk of recurrent UTI post-FMT will be evaluated |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FMT for MDRO UTI Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.
Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | FMT for MDRO UTI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race/Ethnicity, Customized White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Patients With Adverse Events During and After FMT
The number, types, severity, and relation of adverse events to study procedures or product will be analyzed.
Time frame: Six months post-FMT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FMT for MDRO UTI | Number of Patients With Adverse Events During and After FMT | 1 Participants |
Secondary
Number of Patients With Recurrent UTI Post-FMT
Risk of recurrent UTI post-FMT will be evaluated
Time frame: Six months post-FMT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FMT for MDRO UTI | Number of Patients With Recurrent UTI Post-FMT | 1 Participants |