Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization
Condition: Antibiotic Resistant Strain
Intervention: Autologous fecal microbiota transplant (Auto-FMP Enema); Placebo Enema Preparation
Intervention description: FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.; The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Autologous Fecal Microbiota Transplantation

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.
    

Eligibility criteria:

        Inclusion criteria for study enrollment

          1. Long-term care residents associated with Boston University-Boston Medical Center
             nursing home consortium

          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. Pregnant. Participants of childbearing age will undergo urine pregnancy testing

          2. Participant or substitute decision maker unable to provide informed consent

          3. Allergies to following ingredients generally recognized as safe: glycerol and sodium
             chloride

          4. Current enrollment in hospice

          5. Colostomy

          6. Unable to adhere to protocol requirements

          7. 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

          8. Recent travel (last six months) to high risk regions based on the International SOS
             Medical Risk Rating system

          9. Recent exposure (last six months) to unsafe drinking water

        Exclusion criteria for stool collection

        Enrollment stool sample will be tested for ARBs and processed into autologous FMT treatment
        (if of qualifying size). Sample will not be collected if any of the following are true:

          1. Oral or intravenous antibiotic exposure within the previous 6 weeks of stool
             collection date (topical antibiotics will be permitted)

          2. Active gastrointestinal infection at stool collection

          3. Fever at the time of stool collection

          4. Currently ill or complaining of any of the following signs or symptoms of illness:
             fever, diarrhea, blood stools and/or vomiting

          5. Participants with a history of gastrointestinal (GI) illness within the past 30 days
             prior to enrollment stool collection, that at the discretion of the site investigator
             could reasonably be caused by one of the following pathogens: 1) Vibrio spp. 2)
             Norovirus 3) Rotovirus 4) Adenovirus 5) Shiga toxin

        Exclusion criteria for randomization

          -  Colonized with CRE (assessed by PCR or culture assay during enrollment phase)

          -  Colonized with VRE (assessed by PCR or culture assay during enrollment phase)

          -  Colonized with ESBL (assessed by PCR or culture assay during enrollment phase)

          -  Colonized with CDI (assessed by EIA assay on stool collected at enrollment phase)

          -  Treatment with antibiotics which are active against MRSA (i.e. vancomycin or
             linezolid) prior to randomization to FMT intervention or placebo.

          -  Stool culture positive for common enteric pathogens (Salmonella spp., Shigella spp.,
             Campylobacter spp.)

          -  Participants who develop a GI illness with symptoms such as (but not limited to)
             vomiting or diarrhea within 30 days after collection of enrollment stool will be
             evaluated by the site investigator. If the site investigator determines that the
             symptoms were most likely caused by 1) Vibrio spp., 2) Norovirus, 3) Rotavirus, 4)
             Adenovirus, or 5) Shiga toxin, the enrollment stool will be sent out to test for these
             organisms. If the culture is positive for any of these organisms, the participant will
             be excluded from randomization

          -  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

          -  Participants who become severely immunocompromised, as defined by the investigator or
             treating physician, will be excluded prior to receiving intervention