FMT for Multidrug Resistant Organism Reversal
Condition: Infection With Multi-drug Resistant Organisms
MeSH terms: Infections
Intervention: Fecal microbiota transplantation (FMT)
Intervention description: Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: infection; colonization; antibiotic resistance

Summary:

      This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to
      suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with
      recurrent MDRO infections due to organisms of likely enteric origin.

      FMT will be performed on subjects with a history of at least three recurrent infections due
      to MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or
      at least two recurrent infections due to MDRO for which only antimicrobials with rate
      limiting toxicities are available.

      The objective of this protocol is to determine if fecal microbiota transplantation (FMT) will
      be able to prevent additional recurrences of infections due to MDRO by suppressing or
      reversing enteric colonization with MDRO.
    

Eligibility criteria:

        Inclusion criteria will include:

          -  Age ≥18 years old.

          -  Outpatient status at time of FMT.

          -  History of at least three recurrent infections due to an MDRO; at least two recurrent,
             severe infections due to MDRO requiring hospitalization; or at least two recurrent
             infections due to MDRO for which only antimicrobials with rate limiting toxicities
             (see above) are available AND the MDRO is likely of enteric origin. Only MDROs of
             likely enteric origin will be included.

          -  Be without active infection due to the MDRO at the time of FMT.

          -  Not be receiving antimicrobials (therapeutic or suppressive) within 48 hours of FMT.

        Exclusion criteria will include:

          -  Subjects <18 years old.

          -  Subjects unable to be seen as an outpatient.

          -  Use of enteral or systemic antimicrobials at time of FMT.

          -  Planned use of enteral or systemic antimicrobials up to 6 months post-FMT.

          -  Pregnancy or inability/unwillingness to use contraceptives.

          -  Recent intra-abdominal surgery

          -  Short gut syndrome

          -  Gastrointestinal motility disorders

          -  Use of medications that affect intestinal motility an inability to cease using those
             medications at the time of FMT.

          -  Post-allogeneic hematopoietic stem cell transplant recipients with previous or current
             gastrointestinal graft versus host disease.

          -  ANC <500/mm3

          -  HIV+ and not well controlled on antiretroviral therapy, or CD4+ <200/ mm3

          -  At increased risk for peritonitis: presence of intra-abdominal devices, receiving
             peritoneal dialysis, or ascites.

          -  Any acute illness

          -  Recurrent C. difficile infection.

          -  Unlikely to survive for 3 months.

          -  Investigator feels the risks of FMT outweigh potential benefit, including other
             conditions or medications that the investigator determines puts the subject at greater
             risk from FMT.