Status:
COMPLETED
Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
University of British Columbia
University of Calgary
Conditions:
Clostridia Difficile Colitis
Clostridium Difficile Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infe...
Detailed Description
This prospective double blind randomized study will enroll 248 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules. Patients will ...
Eligibility Criteria
Inclusion
- at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
- CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
- Ability to provide informed consent
- Females and males must agree to effective contraception for the duration of the study
Exclusion
- Severe or fulminant colitis
- Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
- Those taking or planning to take an investigational drug within 3 months of enrollment
- Chemotherapy or radiation therapy
- Oropharyngeal or significant esophageal dysphagia
- Ileus or small bowel obstruction
- Pregnant or planning to become pregnant within 3 months
- Breastfeeding or planning to breastfeed during the trial
- Active infection requiring antibiotics
- Life expectancy \<6 months Those with history of total colectomy
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2024
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT03806803
Start Date
March 21 2019
End Date
March 12 2024
Last Update
June 4 2024
Active Locations (5)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
2
University of British Columbia
Vancouver, British Columbia, Canada
3
University of British Columbia
Victoria, British Columbia, Canada, V8R 1J8
4
Mcgill University Health Centre
Montreal, Quebec, Canada