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GI Health Technology Assessment Group

Introduction

This group assesses the effect, properties and the impact of digestive health technology based on evidence-based data through performing systematic review and meta-analyses of diagnostic test accuracy as well as clinical trials. The group will harness the combined expertise of the academic division of gastroenterology at McMaster University’s faculty of Health Sciences, and that of the Farncombe Family Digestive Health Research Institute. The group assesses a spectrum of technologies that include G.I. endoscopy and imaging as well as point-of-care diagnostics using best possible scientific method. The assessments provided by this group are relevant to government, industry as well as healthcare providers.

Related Papers

  • Diagnostic accuracy of EUS compared with MRCP in detecting choledocholithiasis: a meta-analysis of diagnostic test accuracy in head-to-head studies. -
    Meeralam Yaser, Al-Shammari Khalil, Yaghoobi Mohammad et al.
    Gastrointest Endosc. Link: 28645544
    • (Distinguished Poster) Chan BPH, Alrahman MIO, Yaghoobi M. EUS versus MRI in staging rectal cancer: A diagnostic test accuracy meta-analysis. Digestive Disease Week 2018, Washington DC.
    • (Distinguished Poster) Rahman MIO, Chan BPH, Yaghoobi Endoscopic ultrasound versus computed tomography in determining the resectability of pancreatic cancer: a diagnostic test accuracy meta-analysis. Digestive Disease Week 2018, Washington DC.

    People working in this area

    Mohammad Yaghoobi

    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)

    Clinical Psychiatry and Gastrointestinal Interface

    Introduction

    Rebecca Anglin has developed a novel GI Psychiatry clinic that provides integrated psychiatry and psychology treatment to patients with GI illness within the 2F digestive diseases clinic at McMaster. Rebecca Anglin also conducts research on gut-brain interactions in clinical populations including studies in patients with IBD, IBS and the first clinical studies of the gut microbiome in patients with anxiety and other psychiatric disorders.

    People working in this area

    Relevant Papers

  • Anti-inflammatory Intervention in Depression. -
    Anglin Rebecca, Moayyedi Paul, Leontiadis Grigorios I et al.
    JAMA Psychiatry. Link: 25945487
  • Anxiety and Depression Increase in a Stepwise Manner in Parallel With Multiple FGIDs and Symptom Severity and Frequency. -
    Pinto-Sanchez Maria Ines, Ford Alexander C, Avila Christian A et al.
    Am J Gastroenterol. Link: 25964226
  • Risk of upper gastrointestinal bleeding with selective serotonin reuptake inhibitors with or without concurrent nonsteroidal anti-inflammatory use: a systematic review and meta-analysis. -
    Anglin Rebecca, Yuan Yuhong, Moayyedi Paul et al.
    Am J Gastroenterol. Link: 24777151


  • Upper Gastrointestinal Diseases

    Introduction

    The Barrett’s clinic has involved patients in one of the world’s largest randomized trials of this disease evaluating whether we can prevent esophageal cancer using aggressive acid suppression and/or aspirin. Paul Moayyedi is deputy or co-principal investigator in two Barrett’s trials that have enrolled a total of over 5,000 patients. He was also a lead investigator of a study of population Helicobater pylori testing and treatment that evaluated over 8,400 subjects and followed them for over 10 years. David Armstrong was involved in the development of widely accepted international classification systems for both Barrett’s esophagus and gastro-esophageal reflux disease.

    People working in this area

    Relevant Papers

  • Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial. -
    Flook Nigel W, Moayyedi Paul, Dent John et al.
    Am J Gastroenterol. Link: 23147520
  • Effect of population screening and treatment for Helicobacter pylori on dyspepsia and quality of life in the community: a randomised controlled trial. Leeds HELP Study Group. -
    Moayyedi P, Feltbower R, Brown J et al.
    Lancet. Link: 10905240
  • The gain in quality-adjusted life months by switching to esomeprazole in those with continued reflux symptoms in primary care: EncomPASS--a cluster-randomized trial. -
    Moayyedi Paul, Armstrong David, Hunt Richard H et al.
    Am J Gastroenterol. Link: 20842110
  • Prevalence of uninvestigated dyspepsia 8 years after a large waterborne outbreak of bacterial dysentery: a cohort study. -
    Ford Alexander C, Thabane Marroon, Collins Stephen M et al.
    Gastroenterology. Link: 20117111
  • Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial). -
    Delaney Brendan C, Qume Michelle, Moayyedi Paul et al.
    BMJ. Link: 18310262
  • A community screening program for Helicobacter pylori saves money: 10-year follow-up of a randomized controlled trial. -
    Ford Alexander C, Forman David, Bailey Alastair G et al.
    Gastroenterology. Link: 16344059
  • Ethnicity, gender, and socioeconomic status as risk factors for esophagitis and Barrett's esophagus. -
    Ford Alexander C, Forman David, Reynolds P Dominic et al.
    Am J Epidemiol. Link: 16076833
  • The gain in quality-adjusted life months by switching to esomeprazole in those with continued reflux symptoms in primary care: EncomPASS--a cluster-randomized trial. -
    Moayyedi Paul, Armstrong David, Hunt Richard H et al.
    Am J Gastroenterol. Link: 20842110







  • Functional GI Disease

    Introduction

    Paul Moayyedi was involved in a large National Institute of Health funded multicentre randomized controlled trial of antidepressant therapy in functional dyspepsia led by the Mayo clinic. Premsyl Bercik has conducted a phase 2 randomized trial assessing a novel probiotic in patients with mood disorders and irritable bowel syndrome (IBS) and recently completed a pilot study showing the ability of a probiotic bacterium to improve depression in patients with IBS. He has also led a CIHR funded study that has evaluated a cohort of patients with IBS and correlated changes in symptoms with changes in the gut micro biome. John Marshall and Stephen Collins led a series of investigations on the impact of the large outbreak of water poisoning in the town of Walkerton, Ontarion and the development of post-infectious IBS. These studies described the epidemiology, pathophysiology and genetic predisposition to PI-IBS over an 8 year period.

    People working in this area

    Relevant Papers

  • Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study. -
    Talley Nicholas J, Locke G Richard, Saito Yuri A et al.
    Gastroenterology. Link: 25921377
  • The Rome III criteria for the diagnosis of functional dyspepsia in secondary care are not superior to previous definitions. -
    Ford Alexander C, Bercik Premysl, Morgan David G et al.
    Gastroenterology. Link: 24417817
  • Validation of the Rome III criteria for the diagnosis of irritable bowel syndrome in secondary care. -
    Ford Alexander C, Bercik Premysl, Morgan David G et al.
    Gastroenterology. Link: 23994201
  • Eight year prognosis of postinfectious irritable bowel syndrome following waterborne bacterial dysentery. -
    Marshall John K, Thabane Marroon, Garg Amit X et al.
    Gut. Link: 20427395
  • Genetic risk factors for post-infectious irritable bowel syndrome following a waterborne outbreak of gastroenteritis. -
    Villani Alexandra-Chloé, Lemire Mathieu, Thabane Marroon et al.
    Gastroenterology. Link: 20044998
  • Irritable bowel syndrome: a 10-yr natural history of symptoms and factors that influence consultation behavior. -
    Ford Alexander C, Forman David, Bailey Alastair G et al.
    Am J Gastroenterol. Link: 18371141





  • Inflammatory Bowel Disease

    Introduction

    John Marshall and Walter Reinisch are involved in several phase 2 and phase 3 randomized trials that evaluate the latest therapies in both Crohn’s disease and ulcerative colitis (UC).  Walter Reinisch is conducting studies with Wali Khan to assess how fecal calprotectin and be used to optimize the management of IBD patients.  Walter Reinsich is also evaluating novel approaches to managing IBD patients in remote places as well as developing tools that will optimize the quality of care for IBD patients.  Paul Moayyedi, Michael Surette and Christine Lee have led the world’s first randomized trial evaluating fecal microbiota therapy in UC.  Work is currently ongoing to evaluate how this approach can be optimized to treat UC patients.

    People working in this area

    Relevant Papers

  • Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. -
    Moayyedi Paul, Surette Michael G, Kim Peter T et al.
    Gastroenterology. Link: 25857665
  • Lack of utility of symptoms and signs at first presentation as predictors of inflammatory bowel disease in secondary care. -
    Ford Alexander C, Moayyedi Paul, Bercik Premysl et al.
    Am J Gastroenterol. Link: 25916225