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Fecal Microbiota Transplantation (FMT) for MDRO UTI

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal microbiota transplant
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring Urinary tract infection, Multidrug resistant organism, Fecal microbiota transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT for MDRO UTI

Arm Description

Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients With Recurrent UTI Post-FMT
Risk of recurrent UTI post-FMT will be evaluated

Full Information

First Posted
December 5, 2017
Last Updated
March 9, 2022
Sponsor
Washington University School of Medicine
Collaborators
Centers for Disease Control and Prevention, University of Pennsylvania, Duke University, Rush University, Rebiotix Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03367910
Brief Title
Fecal Microbiota Transplantation (FMT) for MDRO UTI
Official Title
Fecal Microbiota Transplantation Using RBX2660 for the Prevention of Recurrent Urinary Tract Infections Due to Multidrug Resistant Organisms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Centers for Disease Control and Prevention, University of Pennsylvania, Duke University, Rush University, Rebiotix Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Urinary tract infection, Multidrug resistant organism, Fecal microbiota transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Participants with eligible MDRO UTIs will receive FMT.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMT for MDRO UTI
Arm Type
Experimental
Arm Description
Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.
Intervention Type
Drug
Intervention Name(s)
Fecal microbiota transplant
Other Intervention Name(s)
Stool transplant
Intervention Description
150mL of FMT product RBX2660 delivered via enema
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events During and After FMT
Description
The number, types, severity, and relation of adverse events to study procedures or product will be analyzed.
Time Frame
Six months post-FMT
Secondary Outcome Measure Information:
Title
Number of Patients With Recurrent UTI Post-FMT
Description
Risk of recurrent UTI post-FMT will be evaluated
Time Frame
Six months post-FMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 <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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Dubberke, MD, MSPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Fecal Microbiota Transplantation (FMT) for MDRO UTI

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