Status:
COMPLETED
Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection
Lead Sponsor:
Vancouver Island Health Authority
Conditions:
Recurrent Clostridium Difficile Infection
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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...
Detailed Description
Recurrence of CDI following a course of standard antibiotic therapy is high, especially in the elderly patients over 65 years of age, in hospitalized and in the immunocompromised patients. As CDI is c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03834038
Start Date
October 1 2015
End Date
March 17 2020
Last Update
September 23 2024
Active Locations (1)
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1
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8