Status:
COMPLETED
FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
University of Calgary
Conditions:
Enterocolitis Clostridium Difficile Recurrent
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized successfully. End...
Detailed Description
Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1 to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1 mon, 3 mon, 6 mon...
Eligibility Criteria
Inclusion
- Age \> 18 and \< 90 years at the time of Screening.
- Diagnosis of at least 3 episodes of recurrent CDI, with each episode defined as presence of diarrhea (\> 3 unformed stools/24 hours) associate with positive stool Clostridium difficle toxin, occurring within 3 months of each other.
- CDI infection under symptomatic control with \< 3 loose/unformed BM's per 24 h period for at least 2 consecutive days before procedure.
- Those with ability to provide informed consent.
Exclusion
- Those with complicated CDI, defined as white blood cell\>35 or \<0.5 x 109/L, significant abdominal pain and distension with evidence of toxic megacolon or pseudomembranous colitis, hypotension defined as systolic blood pressure \< 90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring intensive care unit admission.
- Those with chronic diarrheal illness, such as irritable bowel syndrome or inflammatory bowel disease unless they are in remission for at least 3 months prior to enrollment.
Key Trial Info
Start Date :
September 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2017
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT02254811
Start Date
September 18 2014
End Date
September 13 2017
Last Update
October 24 2019
Active Locations (2)
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1
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8