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

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ClinicalTrials.gov Identifier: NCT03061097
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
Microbiome Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Antibiotic Resistant Strain Biological: Autologous fecal microbiota transplant Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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).

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.

Other: Placebo
Placebo FMT material delivered via enema.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. ARB Colonization [ Time Frame: Day 0, Day 3, Day 7, and Day 28 ]
    Rate of ARB clearance among patients with ARB colonization

  3. 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

  4. 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.



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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 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

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): NCT03061097


Locations
United States, Massachusetts
The Edgar P Benjamin Health Care Center
Boston, Massachusetts, United States, 02120
Sherrill House Inc.
Jamaica Plain, Massachusetts, United States, 02130
Marian Manor Nursing Home
South Boston, Massachusetts, United States, 02127
Sponsors and Collaborators
Microbiome Health Research Institute
Boston Medical Center
Investigators
Principal Investigator: Zain Kassam, MD Microbiome Health Research Institute, (d/b/a OpenBiome)

Responsible Party: Microbiome Health Research Institute
ClinicalTrials.gov Identifier: NCT03061097     History of Changes
Other Study ID Numbers: 200201691946
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 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:
Autologous Fecal Microbiota Transplantation

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents