Status:
COMPLETED
PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial
Lead Sponsor:
McMaster Children's Hospital
Collaborating Sponsors:
St. Justine's Hospital
Conditions:
Crohn Disease
Pediatric Crohns Disease
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief Summary
The objective of this study is to assess the feasibility of a novel colonic and oral fecal microbiota transplantation protocol for the treatment of active pediatric Crohn's disease (CD). Specifically,...
Detailed Description
Several recent studies have assessed the role of fecal microbiota transplantation (FMT) in the treatment of inflammatory bowel disease (IBD). IBD is a chronic autoimmune gastrointestinal disorder that...
Eligibility Criteria
Inclusion
- Pediatric patients
- ≥3yo
- Crohn's disease, or IBD-Unclassified favoring Crohn's disease (as deemed by the patient's primary pediatric gastroenterologist)
- Active symptoms
Exclusion
- Currently enrolled in another clinical trial
- Unable to give informed consent or assent
- Severe comorbid medical illness (at discretion of patient's primary pediatric gastroenterologist)
- Concomitant Clostridium difficile infection
- Severe Crohn's disease flare requiring hospitalization
- Commenced new, or temporary medical therapies (ie. corticosteroids, antibiotics, prebiotics) within 4 weeks prior to commencing the trial; NB: Weaning doses of corticosteroid will be permitted (≤ 0.25mg/kg/day)
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03378167
Start Date
December 1 2018
End Date
September 30 2023
Last Update
October 19 2023
Active Locations (2)
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1
McMaster Children's Hospital
Hamilton, Ontario, Canada, M8V1A4
2
Centre Hospitalier Universitaire Sainte-Justine, University of Montreal
Montreal, Quebec, Canada, H3T 1C5