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Clinical Studies

The GI division prides itself on providing a state of the art service for patients with gastrointestinal disease. Many of the members of the GI division are also affiliated with the Farncombe Family Digestive Health Research Institute and ensure that the majority of new patients that attend a GI clinic are also enrolled in research studies.  The majority of new patients attending the clinic will complete a detailed symptom questionnaire and we intend to add serological and fecal microbial assessment so that all patient are carefully phenotyped.  This provides a powerful database to evaluate GI disease. Furthermore, we have several disease-based clinics such as a Barrett’s clinic, inflammatory bowel disease clinic and a motility/dietary disorders clinic. This ensures patients with complex disease obtain the highest standard of care and also provides a framework that maximizes the ability to conduct clinical research, particularly in the areas of upper GI disease, functional GI disease and inflammatory bowel disease.

Studies Currently Enrolling Subjects

Title: “The Pedi FETCh Research Trial: Pediatric Fecal Transplant for Ulcerative Colitis”

Site Investigator: Dr. N. Pai

Contact: Jelena Popov (Research Coordinator) popovj2@mcmaster.ca / Dr. Nikhil Pai pain@mcmaster.ca / 905.521.2100 ext. 75637

Website: www.fhs.mcmaster.ca/pediatrics/pedifetchresearchtrial

Description:

The Pedi FETCh Research Trial (Pediatric Fecal Transplant for Ulcerative Colitis) is the first pediatric fecal transplant study for inflammatory bowel disease in Canada, and will be the first randomized controlled trial of fecal transplant in pediatric inflammatory bowel disease in the world. The trial is being lead by Dr. Nikhil Pai, and supported by the Division of Pediatric Gastroenterology and Nutrition at McMaster Children’s Hospital. Study collaborators include Dr. Christine Lee (Division of Infectious Disease at St. Joseph’s Hospital in Hamilton), and Paul Moayyedi (Division of Adult Gastroenterology at McMaster University), with support from the Farncombe Digestive Disease Research Institute at McMaster University.

More information, including eligibility, safety monitoring and frequently asked questions, is available on the website.

Title: “The ​role of gut microbiota in gastrointestinal disorders”

Site Investigator: Dr. ​P. Bercik
Contact: Natalia Causada Calo, causadan@mcmaster.ca / Ines Pinto Sanchez, pintosm@mcmaster.ca 905-5​25-9140 x ​21875

Title: “The ​role of gut microbiota in IBS patients”

Site Investigator: Dr. ​P. Bercik
Sponsor: Canadian Institute of Health Research
Contact: Ines Pinto Sanchez, pintosm@mcmaster.ca 905-5​25-9140 x ​21875

Title: “The effect of gluten-free diet on gastrointestinal motility in IBS patients”

Site Investigator: Dr. ​P. Bercik
Sponsor: Boris project
Contact: Ines Pinto Sanchez, pintosm@mcmaster.ca 905-5​25-9140 x ​21875

Title: “A randomized trial of antimicrobials versus placebo in addition to fecal microbiota transplantation for the induction of remission in patients with active ulcerative colitis”

Site Investigators: Dr. Paul Moayyedi and Dr. Christine Lee
Sponsor: the AHSC AFP Innovation Fund
Contact: Melanie Wolfe (Research Coordinator), wolfe@hhsc.ca, 905-521-2100 x 73601

Title: “A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of etrolizumab as an induction and maintenance treatment for patients with moderately to severely active Crohn’s disease”

Site Investigator: Dr. John K. Marshall
Sponsor: Genentech
Contact: Gail Cappelli (905-521-2100 Ext 76986) or Mitzi Lawrence (905-521-2100 Ext 20601)

Title: “Denosumab, a monoclonal antibody to receptor activator of nuclear factor-Kappa B ligand (RANKL), in Crohn’s disease”

Site Investigator: Dr. John K. Marshall
Sponsor: Crohn’s and Colitis Canada
Contact: Gail Cappelli (905-521-2100 Ext 76986) or Mitzi Lawrence (905-521-2100 Ext 20601)

Title: “IBD Genome Medicine Consortium (GenoMed): Translating genetic discoveries into personalized approach to treating the inflammatory bowel-diseases – Development of a tool predictive of response to anti-TNF in a prospective Crohn’s Disease patient cohort”

Site Investigator: Dr. John K. Marshall
Sponsor: Genome Quebec
Contact: Gail Cappelli (905-521-2100 Ext 76986) or Mitzi Lawrence (905-521-2100 Ext 20601)

Title: “Effect of oral Mongersen (GED-0301) on endoscopic and clinical outcomes in subjects with active Crohn’s disease”

Site Investigator: Dr. John K. Marshall
Sponsor: Celgene
Contact: Gail Cappelli (905-521-2100 Ext 76986) or Mitzi Lawrence (905-521-2100 Ext 20601)

Title: “A study to evaluate the pharmacokinetics of adalimumab in combination with methotrexate for the treatment of patients with ulcerative colitis”

Site Investigator: Dr. John K. Marshall
Sponsor: Robarts
Contact: Gail Cappelli (905-521-2100 Ext 76986) or Mitzi Lawrence (905-521-2100 Ext 20601)

Title: “A phase 2 randomised placebo-controlled multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for treatment of subjects with active ulcerative colitis”

Site Investigator: Dr. John K. Marshall
Sponsor: Celgene
Contact: Gail Cappelli (905-521-2100 Ext 76986) or Mitzi Lawrence (905-521-2100 Ext 20601)

Title: “A phase 2, double-blind, randomized, placebo-controlled, multicenter study evaluating the safety and efficacy of GS 5745 in subjects with moderately to severely active Crohn’s disease”

Site Investigator: Dr. John K. Marshall
Sponsor: Gilead
Contact: Gail Cappelli (905-521-2100 Ext 76986) or Mitzi Lawrence (905-521-2100 Ext 20601)

Title: “A combined phase 2/3, double-blind, randomized, placebo controlled, induction and maintenance study evaluating the safety and efficacy of GS-5745 in subjects with moderately to severely active ulcerative colitis”

Site Investigator: Dr. John K. Marshall
Sponsor: Gilead
Contact: Gail Cappelli (905-521-2100 Ext 76986) or Mitzi Lawrence (905-521-2100 Ext 20601)

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