Fecal Microbiota Transplantation (FMT) for MDRO UTI

NCT03367910 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 201708204
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

Urinary tract infection; Multidrug resistant organism; Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

  Six months post-FMT

Secondary Outcomes (1)

• Number of Patients With Recurrent UTI Post-FMT

  Six months post-FMT

Study Arms (1)

FMT for MDRO UTI

EXPERIMENTAL

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

Drug: Fecal microbiota transplant

Interventions

Fecal microbiota transplant DRUG

150mL of FMT product RBX2660 delivered via enema

Also known as: Stool transplant

FMT for MDRO UTI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Centers for Disease Control and Prevention: collaborator
• University of Pennsylvania: collaborator
• Duke University: collaborator
• Rush University: collaborator
• Rebiotix Inc.: collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Kimberly Reske, Research Coordinator
• Organization: Washington University in St. Louis School of Medicine

kreske@wustl.edu

3147474041

Study Officials

• Erik Dubberke, MD, MSPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with eligible MDRO UTIs will receive FMT.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: February 8, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 18, 2022
• Results First Posted: February 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)