Fecal Microbiota Transplant Trial for Children with Crohn’s Disease

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McMaster Children’s Hospital is looking for children ages 3 to 17 years old, diagnosed with Crohn’s disease or IBD-U to participate in the first Health Canada approved fecal microbiota transplant (FMT) trial for children suffering from Crohn’s disease across Canada.

The PediCRaFT (Pediatric CRohn’s Disease Fecal Microbiota Transplant) Trial is the first Health Canada approved fecal microbiota transplant (FMT) trial for children with Crohn’s disease across Canada. This trial is being led by the McMaster Pediatric Fecal Microbiota Transplant program, under the supervision of Dr. Nikhil Pai, pediatric gastroenterologist at McMaster Children’s Hospital. The team has extensive experience in pediatric FMT, having recently completed a three-year randomized trial of FMT in children with ulcerative colitis. We collaborate closely with leaders in FMT Research through the McMaster University Division of Adult Gastroenterology, and McMaster University Farncombe Family Digestive Health Research Institute.

FMT

Who is eligible? 

Children ages 3 to 17 years old, diagnosed with Crohn’s disease or IBD-U. Please contact our research coordinator for further details about eligibility. We would be pleased to contact your primary gastroenterology team on your behalf if you are interested in becoming involved.

Study Involves:

i) Colonoscopy (optional): Patients will have baseline disease severity assessed through colonoscopy, and receive their first FMT infusion into the terminal ileum. The initial colonoscopy (performed by a pediatric gastroenterologist and supervised by pediatric anesthesia, and endoscopy nursing staff, will take place through McMaster Children’s Hospital’s outpatient pediatric endoscopy suite.

ii) Rectal enema (optional): Patients may receive their first FMT infusion as a rectal enema instead of colonoscopy, depending on availability and patient preference. This is done through the McMaster Children’s Hospital outpatient Pediatric Gastroenterology & Nutrition clinic. This can be discussed with the research team at time of enrolment.

iii) Oral FMT Capsule (6 weeks): Twice per week, for 6 weeks, you will be given oral FMT capsules that you will be instructed to  take at home.

We will ask you to provide:

1.) Bloodwork
2.) Urine samples
3.) Stool samples
4.) Complete a 6-Question survey

Ethics Approvals:

This study has been approved by Health Canada, and the Hamilton Integrated Research Ethics Board. Extensive regulatory approvals and testing has been performed on all FMT samples. The trial is run by an experienced pediatric gastroenterology team through McMaster’s Pediatric Fecal Microbiota Transplant program.

To participate or learn more, please contact:

Lee Hill, BSc (Med)(Hons), PhD (c) hillle@hhsc.ca
Phone: 514-443-8488

Principal Investigator:
Dr Nikhil Pai, BSc MD CNSC FAAP FRCPC

Associate Professor, Department of Pediatrics (McMaster University)
Division of Pediatric Gastroenterology & Nutrition, McMaster Children’s Hospital

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McMaster Children's Hospital