Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03367910
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2017-12-05
Brief Title:
Fecal Microbiota Transplantation FMT for MDRO UTI
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Fecal Microbiota Transplantation Using RBX2660 for the Prevention of Recurrent Urinary Tract Infections Due to Multidrug Resistant Organisms
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 individuals 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None