NCT03367910

Fecal Microbiota Transplantation (FMT) for MDRO UTI

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Fecal microbiota transplant	150mL of FMT product RBX2660 delivered via enema

Timeline

• Start date: 2018-02-08
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-12-11
• Last updated: 2022-03-18
• Results posted: 2022-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study