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Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization (RACE)

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: NCT03061097
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
Microbiome Health Research Institute

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
Safety (short-term) defined as absence of NIH Grade ≥2 adverse events including IND safety reporting criteria [ Time Frame: 7 days ]
Safety (short-term) at day 7 defined as absence of NIH Grade ≥2 adverse events including IND safety reporting criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • Microbiome Disruption Index (MDI) [ Time Frame: Day 0, Day 3, Day 7, and Day 28 ]
    Microbiome disruption indices (16S rRNA sequencing): MDI-community and MDI-species at baseline (pre-infection on the date of stool collection), post-antibiotics on the intervention/placebo date (Day 0, Day 3, Day 7, and Day 28). MDI will be applied to pre- and post-intervention communities in comparison to baseline and reference communities.
  • ARB Colonization [ Time Frame: Day 0, Day 3, Day 7, and Day 28 ]
    Rate of ARB clearance among patients with ARB colonization
  • ARB-associated clinical infectionDay 3, Day 7, Day 28, and Month 6. [ Time Frame: Day 3, Day 7, Day 28, and Month 6 ]
    Composite endpoint for presence of any ARB-associated clinical infection
  • Safety (intermediate and long-term) defined as NIH Grade ≥2 adverse events. [ Time Frame: Day 28 and Month 6 ]
    Safety (intermediate at Day 28 and long-term at Month 6) defined as NIH Grade ≥2 adverse events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization
Official Title  ICMJE Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria
Brief Summary This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Antibiotic Resistant Strain
Intervention  ICMJE
  • Biological: Autologous fecal microbiota transplant
    Fecal Microbiota Transplant (FMT) FMT is the process by which processed donor microbiota material is transplanted into recipients, by either upper or lower gastrointestinal delivery. The aim is to reconstitute the normal intestinal microbial flora in recipients. FMT can be administered by either enema or capsule depending on eligibility criteria. In this study, the fecal microbiota preparation will be made from the participant's own stool (autologous FMT).
  • Other: Placebo
    Placebo FMT material delivered via enema.
Study Arms  ICMJE
  • Experimental: Treatment (autologous fecal microbiota preparation)

    Autologous treatment preparation: Patient stool will be collected and processed into an auto-fecal microbiota preparation (FMP) formulation. In this treatment arm, the auto-FMP will be administered to the participant following an infectious episode requiring antibiotics.

    V-A Auto-FMP Enema (125 mL):

    Route of Administration: Enema nozzle will be inserted into rectum and contents expelled into the distal colon. Target dwell time is 1 hour. Participants will lie in the left lateral decubitas position but if mobility permits will rotate to supine and right lateral decubitus position.

    Dosing Regimen: 125mL x 1 dose

    Intervention: Biological: Autologous fecal microbiota transplant
  • Placebo Comparator: Placebo

    Participants randomized to the placebo arm will receive a placebo FMT via enema. The placebo enema preparation interventional enema in appearance.

    The placebo enema preparation will be comprised of Sodium Chloride (0.9%, USP), Glycerol (12.5%, USP), and 8-12 drops brown food coloring (<1%), to prevent unmasking of the trial arms.

    Intervention: Other: 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: July 16, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2017)
180
Actual Study Completion Date  ICMJE June 18, 2019
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria for study enrollment

  1. Long-term care residents in Boston
  2. Adults (18 years or older)

Inclusion criteria for randomization

1) Infection requiring antimicrobial treatment at the discretion of the treating physician

Exclusion criteria for study enrollment

  1. Oral or intravenous antibiotic exposure within the previous 6 weeks of stool collection date. -Topical antibiotics will be permitted
  2. Gastrointestinal (GI) symptoms such as (but not limited to) vomiting or diarrhea 30 days prior to stool collection
  3. Participant or substitute decision maker unable to provide informed consent
  4. Active gastrointestinal infection at stool collection
  5. Fever at the time of stool collection
  6. Patients with allergies to following ingredients Generally Recognized as Safe: glycerol and sodium chloride
  7. Life expectancy <6 months
  8. Unable to adhere to protocol requirements
  9. Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
  10. Stool culture positive for common enteric pathogens (Salmonella spp., Shigella spp., Campylobacter spp.)
  11. Recent travel (last six months) to high risk regions based on the International SOS Medical Risk Rating system
  12. Recent exposure (last six months) to unsafe drinking water

Exclusion criteria for randomization

  • History of gastrointestinal (GI) symptoms such as (but not limited to) vomiting or diarrhea 30 days post collection of enrollment stool.
  • Stool testing positive for common enteric pathogens
  • Colonized with CRE (assessed by PCR assay on stool collected at biobanking phase)
  • Colonized with VRE (assessed by PCR assay on stool collected at biobanking phase)
  • Colonized with ESBL (assessed by PCR assay on stool collected at biobanking phase)
  • Colonized with CDI (assessed by EIA assay on stool collected at biobanking phase)
  • Treatment with antibiotics which are active against MRSA (i.e. vancomycin or linezolid) prior to randomization to FMT intervention or placebo.
  • Any condition that the physician investigators deems unsafe
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 NCT03061097
Other Study ID Numbers  ICMJE 200201691946
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 Boston Medical Center
Investigators  ICMJE
Principal Investigator: Zain Kassam, MD Microbiome Health Research Institute, (d/b/a OpenBiome)
PRS Account Microbiome Health Research Institute
Verification Date July 2019

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