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A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization

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ClinicalTrials.gov Identifier: NCT03063437
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : June 29, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 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
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Active
encapsulated fecal microbiota preparation
Biological: Encapsulated fecal microbiota preparation
30 capsules

Placebo Comparator: Placebo
encapsulated placebo
Biological: Encapsulated placebo
30 capsules




Primary Outcome Measures :
  1. Proportion of participants with VRE decolonization [ Time Frame: Day 10 (±3 days) after randomization ]
    Proportion of participants with VRE decolonization

  2. 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)


Secondary Outcome Measures :
  1. Incidence of VRE infection within 4 weeks following FMT [ Time Frame: Day 3 (±1 days), day 10 (± 3 days), week 4 (±5 days) after randomization ]
    Proportion of participants with VRE infection

  2. Incidence of ARB colonization on Day 10 following FMT [ Time Frame: Day 10 (± 3 days) after randomization ]
    Proportion of participants with other antibiotic resistant bacteria (ARB) colonization

  3. Incidence of ARB infection within 4 weeks following FMT [ Time Frame: Up to 4 weeks after randomization ]
    Proportion 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 ]
    Proportion of participants with VRE decolonization among immunocompromised patients

  6. VRE decolonization among patients 65 years or older [ Time Frame: Day 10 (± 3 days) after randomization ]
    Proportion of participants with VRE decolonization among 65 years or older

  7. Adverse events within 4 weeks following FMT [ Time Frame: Through week 4 (±5 days) after randomization ]
    Proportion of participants with an AE

  8. Serious adverse events within 4 weeks following FMT [ Time Frame: Through week 4 (±5 days) after randomization ]
    Proportion of participants with an SAE

  9. 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)

  10. 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


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



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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 7 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.

    • 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.

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 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.
  • Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks.
  • 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


Contacts
Contact: Zain Kassam, MD, MPH, FRCPC 617-229-6499 zain@openbiome.org
Contact: Audrey Abend, BA 617-575-2201 audrey@openbiome.org

Locations
United States, Indiana
IU Health University Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Wisconsin
University of Wisconsin University Hospital Recruiting
Madison, Wisconsin, United States, 53792
Contact: Dan Finlay    608-256-1901 ext 17727      
Contact: Lauren Barko    608-256-1901 ext 13131      
Principal Investigator: Nasia Safdar, MD, PhD         
Sponsors and Collaborators
Microbiome Health Research Institute
University of Wisconsin, Madison
Indiana University

Responsible Party: Microbiome Health Research Institute
ClinicalTrials.gov Identifier: NCT03063437     History of Changes
Other Study ID Numbers: 200-2016-91948
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents