Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03063437
Recruitment Status : Completed
First Posted : February 24, 2017
Results First Posted : February 5, 2020
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
University of Wisconsin, Madison
Indiana University
Information provided by (Responsible Party):
Microbiome Health Research Institute

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE February 24, 2017
Results First Submitted Date  ICMJE January 15, 2020
Results First Posted Date  ICMJE February 5, 2020
Last Update Posted Date April 13, 2020
Actual Study Start Date  ICMJE August 17, 2017
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • Proportion of Participants With VRE Decolonization [ Time Frame: Day 10 (±3 days) after randomization ]
    Proportion of participants with VRE decolonization
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Day 10 (±3 days) after randomization ]
    Proportion 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • Percentage of Participants With VRE Infection [ Time Frame: Week 4 (±5 days) after randomization ]
    Percentage of participants with VRE infection, defined as an associated bacteremia, urinary tract infection, or wound-related infection.
  • Percentage of Participants With ARB Colonization on Day 10 Following Fecal Microbiota Transplantation (FMT) [ Time Frame: Day 10 (± 3 days) after randomization ]
    Percentage of participants with other antibiotic resistant bacteria (ARB) colonization
  • Percentage of Participants With ARB Infection 4 Weeks Following FMT [ Time Frame: Week 4 (±5 days) after randomization ]
    Percentage of participants with composite ARB infection
  • Number of Days Between FMT and VRE Colonization and Infection Occurs [ Time Frame: Up to 6 months after randomization ]
    Time (in days) from randomization until the study day when VRE colonization and infection occurs
  • VRE Decolonization Among Immunocompromised Patients [ Time Frame: Day 10 (± 3 days) after randomization ]
    Percentage of participants with VRE decolonization among immunocompromised patients
  • Adverse Events Within 4 Weeks Following FMT [ Time Frame: Week 4 (±5 days) after randomization ]
    Percentage of participants with an adverse event (AE)
  • Serious Adverse Events Within 4 Weeks Following FMT [ Time Frame: Week 4 (±5 days) after randomization ]
    Percentage of participants with a serious adverse event (SAE)
  • Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI) [ Time Frame: Week 4 (±5 days) after randomization ]
    Percentage of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI)
  • Serious Adverse Events Within 6 Months Following FMT [ Time Frame: Month 6 (±14 days) phone safety assessment after randomization ]
    Percentage of participants with a Serious Adverse Event (SAE)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • Incidence of VRE Infection Within 4 Weeks Following FMT [ Time Frame: Day 3 (±1), day 10 (± 3), week 4 (±5 days) after randomization ]
    Proportion of participants with VRE infection
  • Incidence of ARB Colonization on Day 10 Following FMT [ Time Frame: Day 10 (± 3) after randomization ]
    Proportion of participants with other antibiotic resistant bacteria (ARB) colonization
  • Incidence of ARB Infection Within 4 Weeks Following FMT [ Time Frame: Up to 4 weeks after randomization ]
    Proportion of participants with composite ARB infection
  • Number of Days Between FMT and VRE Colonization and Infection Occurs [ Time Frame: Up to 6 months after randomization ]
    Time (in days) from randomization until the study day when VRE colonization and infection occurs
  • VRE Decolonization Among Immunocompromised Patients [ Time Frame: Day 10 (± 3) after randomization ]
    Proportion of participants with VRE decolonization among immunocompromised patients
  • VRE Decolonization Among Patients 65 Years or Older [ Time Frame: Day 10 (± 3) after randomization ]
    Proportion of participants with VRE decolonization among 65 years or older
  • Adverse Events Within 4 Weeks Following FMT [ Time Frame: Through week 4 (±5 days) after randomization ]
    Proportion of participants with an AE
  • Serious Adverse Events Within 4 Weeks Following FMT [ Time Frame: Through week 4 (±5 days) after randomization ]
    Proportion of participants with an SAE
  • Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI) [ Time Frame: Through week 4 (±5 days) after randomization ]
    Proportion of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI)
  • Serious Adverse Events Within 6 Months Following FMT [ Time Frame: Month 6 (±14 days) phone safety assessment after randomization ]
    Proportion of participants with a SAE
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2017)
  • Microbiome Disruption [ Time Frame: Day 3, day 10, week 4 after randomization. ]
    To evaluate the microbiome disruption index (MDI) by 16s rRNA sequencing): MDI-community and MDI-species
  • Engraftment Dynamics [ Time Frame: 6 months following FMT ]
    To evaluate the trends in VRE type/strain-level engraftment using whole genome sequencing among those colonized
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization
Official Title  ICMJE Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group Trial of Encapsulated Fecal Microbiota Transplantation for Vancomycin Resistant Enterococcus Decolonization
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Antibiotic Resistant Strain
Intervention  ICMJE
  • Biological: Encapsulated fecal microbiota preparation
    30 capsules
  • Biological: Encapsulated placebo
    30 capsules
Study Arms  ICMJE
  • Experimental: Active: Encapsulated Fecal Microbiota Preparation
    Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
    Intervention: Biological: Encapsulated fecal microbiota preparation
  • Placebo Comparator: Placebo: Encapsulated Placebo
    Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, and 28 days, and 6 months.
    Intervention: Biological: Encapsulated placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
9
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2017)
46
Actual Study Completion Date  ICMJE February 26, 2019
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy. Patients on maintenance chemotherapy may be enrolled only after consultation with medical monitor.
  • Unable or unwilling to comply with protocol requirements.
  • Expected life expectancy < 6 months
  • Previous FMT or microbiome-based products at any time excluding this study.
  • Patients with a history of severe anaphylactic or anaphylactoid food allergy.
  • Solid organ transplant recipients ≤ 90 days post-transplant or on active treatment for rejection.
  • Neutropenia (≤500 neutrophils/mL) or other severe immunosuppression. Anti-TNF will be permitted. Patients on monoclonal antibodies to B and T cells. glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine, methotrexate), calcineurin inhibitors (tacrolimus, cyclosporine) and mycophenolate mofetil may be enrolled only after consultation with the medical monitor.
  • If at risk for CMV/EBV associated disease (at investigator's discretion, e.g. immunocompromised), negative IgG testing for cytomegalovirus (CMV) or Epstein Barr Virus (EBV).
  • A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03063437
Other Study ID Numbers  ICMJE 200-2016-91948
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Microbiome Health Research Institute
Study Sponsor  ICMJE Microbiome Health Research Institute
Collaborators  ICMJE
  • University of Wisconsin, Madison
  • Indiana University
Investigators  ICMJE
Principal Investigator: Majdi Osman, MD, MPH Microbiome Health Research Institute d/b/a OpenBiome
PRS Account Microbiome Health Research Institute
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP