A Prospective Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Intervention: Fecal Microbiota Transplant
Intervention description: All eligible patients will receive fecal microbiota transplant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary goal of this proposal is to study the outcome of patients with recurrent
      Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation
      (FMT) in an open-labelled controlled trial. The specific objectives are to evaluate the
      safety of FMT and to determine the clinical response, treatment failure and relapse rate in
      patients treated with frozen-and-thawed FMT; to assess the functional health and well-being
      of patients in each arm using the validated tool, and to determine the feasibility of
      providing standardized FMT in multiple centres across Canada, including community hospitals.
      The metagenomics will also be conducted from the stool samples collected from select patients
      from each arm: pre and post treatment and the matching donors. The metagenomics data will be
      used to determine the bacteria which may have contributed to the cure of CDI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or older.

          2. Able to provide informed consent.

          3. Laboratory or pathology confirmed diagnosis of recurrent CDI with symptoms (defined
             below) within the previous 180 days.

          4. ≥ 2 episodes of CDI within 6 months and/or ongoing symptoms consistent with CDI
             despite treatment with oral vancomycin at a dose of at least 125 mg 4 times daily for
             at least 5 days.

        Exclusion Criteria:

          1. Planned or actively taking an investigational product for another study.

          2. Patients with neutropenia with absolute neutrophil count <0.5 x 109/L

          3. Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray

          4. Peripheral white blood cell count > 30.0 x 109/L AND temperature > 38.0 oC

          5. Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli,
             Yersinia or Campylobacter.

          6. Presence of colostomy or ileostomy.

          7. Unable to tolerate FMT or enema for any reason.

          8. Anticipated requirement for systemic antibiotic therapy for more than 7 days during
             the 12 week study period.

          9. Actively taking Saccharomyces boulardii or probiotics other than yogurt.

         10. No symptoms consistent with CDI, off CDI antibiotic therapy for 3 or more weeks

         11. Severe underlying disease such that the patient is not expected to survive for at
             least 30 days.

         12. Any condition that, in the opinion of the investigator, that the treatment may pose a
             health risk to the subject.