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

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.

Condition or disease Intervention/treatment Phase
Antibiotic Resistant Strain Biological: Encapsulated fecal microbiota preparation Biological: Encapsulated placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group Trial of Encapsulated Fecal Microbiota Transplantation for Vancomycin Resistant Enterococcus Decolonization
Actual Study Start Date : August 17, 2017
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : February 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
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.
Biological: Encapsulated fecal microbiota preparation
30 capsules

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.
Biological: Encapsulated placebo
30 capsules




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. VRE Decolonization Among Immunocompromised Patients [ Time Frame: Day 10 (± 3 days) after randomization ]
    Percentage of participants with VRE decolonization among immunocompromised patients

  6. Adverse Events Within 4 Weeks Following FMT [ Time Frame: Week 4 (±5 days) after randomization ]
    Percentage of participants with an adverse event (AE)

  7. 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)

  8. 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)

  9. 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)


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063437


Locations
Layout table for location information
United States, Indiana
IU Health University Hospital
Indianapolis, Indiana, United States, 46202
United States, Wisconsin
University of Wisconsin University Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Microbiome Health Research Institute
University of Wisconsin, Madison
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Majdi Osman, MD, MPH Microbiome Health Research Institute d/b/a OpenBiome
  Study Documents (Full-Text)

Documents provided by Microbiome Health Research Institute:
Layout table for additonal information
Responsible Party: Microbiome Health Research Institute
ClinicalTrials.gov Identifier: NCT03063437    
Other Study ID Numbers: 200-2016-91948
First Posted: February 24, 2017    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Microbiome Health Research Institute:
vancomycin resistant enterococcus
VRE
decolonization
VRE colonization
fecal microbiota transplantation
FMT
FMT capsule
capsule
antimicrobial resistance
antibiotic resistance
MDRO
multidrug-resistant organism
OpenBiome
Additional relevant MeSH terms:
Layout table for MeSH terms
Sprains and Strains
Wounds and Injuries