Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group Trial of Encapsulated Fecal Microbiota Transplantation for Vancomycin Resistant Enterococcus Decolonization

Microbiome Health Research Institute2 sites in 1 country9 target enrollmentAugust 17, 2017

ConditionsAntibiotic Resistant Strain

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Antibiotic Resistant Strain
Sponsor: Microbiome Health Research Institute
Enrollment: 9
Locations: 2
Primary Endpoint: Percentage of Participants With VRE Decolonization
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

August 17, 2017

End Date

February 26, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Microbiome Health Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults 18 years or older at the time of enrollment.
•Able to provide signed and dated informed consent.
•Identified as VRE-positive by a stool culture within last 14 days.
•Women of childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment.
•Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception\*.
•Includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy.
•Includes, but is not limited to, barrier with additional spermicidal foam or jelly and vasectomy.

Exclusion Criteria

•Female patient who are pregnant, lactating or planning on becoming pregnant during study. Female patients of childbearing potential will undergo a pregnancy test, and be excluded from the study if positive.
•Inability (e.g. dysphagia) to or unwilling to swallow capsules.
•Active antibiotic resistant bacteria (ARB) or gastrointestinal infection at time of enrollment.
•Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to randomization. Does not include antibiotics used for prophylaxis or topical antibiotics.
•Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks. Does not include antibiotics used for prophylaxis or topical antibiotics.
•Unwilling to withhold probiotics for a minimum of 48 hours prior to providing a screening stool sample.
•Known or suspected toxic megacolon and/or known small bowel ileus.
•Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
•History of total colectomy or bariatric surgery.
•Admitted to or expected to an intensive care unit for medical reasons (not just boarding). Patients residing in a nursing home, long-term care facility or rehabilitation center may be enrolled.

Outcomes

Primary Outcomes

Percentage of Participants With VRE Decolonization

Time Frame: Day 10 (±3 days) after randomization

VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at 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)

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) through Day 10 (± 3 days) after randomization.

Secondary Outcomes

Number of Days Between FMT and VRE Colonization and Infection Occurs(Up to 6 months after randomization)
VRE Decolonization Among Immunocompromised Patients(Day 10 (± 3 days) after randomization)
Percentage of Participants With VRE Infection(Week 4 (±5 days) after randomization)
Percentage of Participants With ARB Colonization on Day 10 Following Fecal Microbiota Transplantation (FMT)(Day 10 (± 3 days) after randomization)
Percentage of Participants With ARB Infection 4 Weeks Following FMT(Week 4 (±5 days) after randomization)
Serious Adverse Events Within 4 Weeks Following FMT(Week 4 (±5 days) after randomization)
Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)(Week 4 (±5 days) after randomization)
Adverse Events Within 4 Weeks Following FMT(Week 4 (±5 days) after randomization)
Serious Adverse Events Within 6 Months Following FMT(Month 6 (±14 days) phone safety assessment after randomization)