Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection

Inclusion Criteria

• Age ≥ 12 years or older.
• Able to provide informed consent.
• Willing and able to comply with all the required study procedures.
• A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment unless patient taking treatment specifically for CDI for more than 3 months.
• History of at least ≥ 2 recurrent CDI where recurrence is defined as return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy for each episode and/or ongoing symptoms consistent with CDI* (defined below) despite at least 7 days of treatment using oral vancomycin at a minimum dose of 250 mg four times daily.
• Symptoms of CDI include: diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea

Exclusion Criteria

• Planned or actively taking another investigational product
• CDI symptom-free for 3 or more weeks following completion of CDI treatment
• Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
• Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
• Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
• Presence of colostomy
• Unable to tolerate FMT or enema for any reason.
• Requiring systemic antibiotic therapy for more than 7 days.
• Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed
• Severe underlying disease such that the patient is not expected to survive for at least 30 days.