The objective of this study is to provide preliminary insight into the safety and efficacy of fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of vancomycin-resistant Enterococcus.
Note: The Protocol and Statistical Analysis Plan document contains modifications from what is on file at the FDA to reflect redactions and formatting requirements for public posting on ClinicalTrials.gov.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
30 capsules
30 capsules
IU Health University Hospital
Indianapolis, Indiana, United States
University of Wisconsin University Hospital
Madison, Wisconsin, United States
Percentage of Participants With VRE Decolonization
VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.
Time frame: Day 10 (±3 days) after randomization
Percentage of Participants With an Adverse Event (AE); Severe Adverse Event (SAE); and Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
Percentage of participants with an adverse event (AE); severe adverse event (SAE); and newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through Day 10 (± 3 days) after randomization.
Time frame: Day 10 (±3 days) after randomization
Percentage of Participants With VRE Infection
Percentage of participants with VRE infection, defined as an associated bacteremia, urinary tract infection, or wound-related infection.
Time frame: Week 4 (±5 days) after randomization
Percentage of Participants With ARB Colonization on Day 10 Following Fecal Microbiota Transplantation (FMT)
Percentage of participants with other antibiotic resistant bacteria (ARB) colonization
Time frame: Day 10 (± 3 days) after randomization
Percentage of Participants With ARB Infection 4 Weeks Following FMT
Percentage of participants with composite ARB infection
Time frame: Week 4 (±5 days) after randomization
Number of Days Between FMT and VRE Colonization and Infection Occurs
Time (in days) from randomization until the study day when VRE colonization and infection occurs
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Time frame: Up to 6 months after randomization
VRE Decolonization Among Immunocompromised Patients
Percentage of participants with VRE decolonization among immunocompromised patients
Time frame: Day 10 (± 3 days) after randomization
Adverse Events Within 4 Weeks Following FMT
Percentage of participants with an adverse event (AE)
Time frame: Week 4 (±5 days) after randomization
Serious Adverse Events Within 4 Weeks Following FMT
Percentage of participants with a serious adverse event (SAE)
Time frame: Week 4 (±5 days) after randomization
Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
Percentage of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI)
Time frame: Week 4 (±5 days) after randomization
Serious Adverse Events Within 6 Months Following FMT
Percentage of participants with a Serious Adverse Event (SAE)
Time frame: Month 6 (±14 days) phone safety assessment after randomization