PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (PediCRaFT)
Crohn Disease, Pediatric Crohns Disease, Inflammatory Bowel Diseases
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Paediatrics, Pediatrics, Crohn's, Crohn, Microbiome, Microbiota, FMT, Fecal Transplant, Fecal Microbiota Transplant, IBD-U, Inflammatory Bowel Disease Unclassified, Inflammatory Bowel Disease Indeterminate, IBD, Colitis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- McMaster Children's Hospital
- Centre Hospitalier Universitaire Sainte-Justine, University of Montreal
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MICROBIOTA
PLACEBO
Patients randomized to the INTERVENTION arm will receive a baseline fecal microbiota transplant (FMT) colonoscopic infusion at Week 0, followed by twice-weekly oral microbiota capsule (OMC) therapy for 6 weeks (including Week 0). (n = 30)
Patients randomized to the CONTROL arm will receive a baseline normal saline (NS) colonoscopic infusion at Week 0, followed by twice-weekly dextrose-containing oral placebo capsule (OPC) therapy for 6 weeks (including Week 0). (n = 15)