Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vancouver Island Health Authority

Criteria

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, E. coli 0157H7, 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.