Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection
Canada158 participantsStarted 2015-10-01
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ā„ 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 ā„ 2 recurrent CDI where recurrence is deļ¬ned 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 deļ¬ned 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.
* Acā¦
What they're measuring
1
No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT