Gastroenterology
The Gastroenterology Department at St. James’s Hospital has long established clinical and translational research programmes conducting a broad range of investigator-led and industry-sponsored studies in variety of subspecialty areas of GI disease. The department has a particular focus on studies in inflammatory bowel disease including ulcerative colitis and Crohn’s disease. The group also has a strong interest in and an active clinical trial portfolio in the area of gastrointestinal neuroendocrine tumours.
| Study Name | Study Title | Study type | Sponsor | Sponsor Type |
|---|---|---|---|---|
| GOAL-ARC | Golimumab dose Optimisation to adequate levels to achieve response in Colitis | Clinical trial (NCT02687724) (2015-004724-62) | UCD | Academic |
| Abbvie UC | A Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Clinical Trial (NCT02819635) (2016-000641-31) | AbbVie | Industry |
| Abbvie OLE M14-533 | A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC) | Clinical Trial (NCT03006068) (2016-000674-38) | AbbVie | Industry |
| DIVERSITY | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Clinical trial (NCT02914600)(2016-001367-36) | Gilead Sciences | Industry |
| DIVERSITY OLE | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Clinical trial (NCT02914561)(2016-002763-34) | Gilead Sciences | Industry |
| Sublimity CYC-202 | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Clinical Trial | Sublimity Therapeutics | Industry |
| N/A | Pharmacogenomic markers of biologic therapy outcome in Inflammatory Bowel Disease | Observational study | INITIative | Academic |
| N/A | Human colonic tissue ex-plants explants as precision medicine tools in Inflammatory Bowel Disease | Observational study | N/A | Academic |
| GMI-IBD | The Genomic Basis of Inflammatory Bowel Disease (IBD) in Ireland – St. James Hospital | Observational study with blood tests | Genuity Science | Commercial: Industry |
| Vedolizumab | Impact of Induction Vedolizumab pharmacokinetics on Induction and maintenance therapy outcome in inflammatory bowel disease | Observational with radiology or blood tests | Takeda | Commercial: Industry |
| Unintentional Weight Loss and Oesophagectomy | Mechanism and Treatment of Unintentional Weight Loss after Oesophagectomy with Curative intent. | Observational with radiology or blood tests | IRC | Non-commercial: Academic |
| The PRE-HIIT Trial | Preoperative Exercise to Improve Fitness in Patients Undergoing Complex Surgery for Cancer of the Lung or Oesophagus: The PRE-HIIT Trial | Observational with radiology or blood tests | HRB and MCRB | |
| Restore SWAT | Development of a patient designed participant information leaflet for the future ReStOre II trial – A Public and Patient Involvement initiative | Observational-non invasive | HRB | Non-commercial: Academic |
| ReStOre at Home | Rehabilitation Strategies following Oesophagogastric and Hepatopancreaticobiliary Cancer: ReStOreII - A Randomised Controlled Trial | Observational with radiology or blood tests | National (Government agency) | |
| ReStOre B | Rehabilitation Strategies following Oesophagogastric and Hepatopancreaticobiliary Cancer: ReStOreII - A Randomised Controlled Trial | Observational with radiology or blood tests | National (Government agency) |
| Study Name | Study Title | Study Type | Sponsor | Sponsor Type |
|---|---|---|---|---|
| Clarinet Forte | Efficacy and safety of lanreotide autogel 120mg administered every 14 days in well differentiated metastatic or locally advanced unresectable pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide autogel 120mg administered every 28 days | Clinical trial | IPSEN | Industry |
| GEM Project | A multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel Disease | Observational-non invasive | N/A | Academic |
| Pouchitis | A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis | Clinical trial | Atlantic Pharmaceuticals | Industry |
| MOBIDIC | Molecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC)Detection study In Crohn's disease patients (MOBIDIC) Version Modification | Observational with radiology or blood tests | French Research Consortium | Industry |
| N/A | Biomarkers and Drug Pharmacokinetic Factors Associated with Vedolizumab Therapy Outcome in Inflammatory Bowel Disease | Prospective observational study | N/A | Academic |
| REMINET | A European, multicentre, Phase II/III randomised Double-Blind, Placebo controlled study evaluating lanreotide as maintenance therapy in patients with non-resectable duodeno-pancreatic neuroendocrine tumours after first-line treatment | Clinical trial | French Research Consortium | Academic |
| Buffet Lunch | Food intake and food preference in patients with upper gastrointestinal surgery - Buffet lunch study | Nutritional Trial | Health Research Board | Non-commercial: Academic |
| EndoGut1 | Characterisation of changes in gut mucosal function after upper gastrointestinal surgery (EndoGut 1) | Observational with invasive tests | Health Research Board | Non-commercial: Academic |
| EndoGut2 | Characterisation of changes in gut mucosal function after upper gastrointestinal surgery (EndoGut 2) | Observational with invasive tests | Health Reearch Board | Non-commercial: Academic |
| GOAL-MARC | Golimumab dose Optimisation to Adequate Levels - Markers Predicting Response in Colitis | Observational with radiology or blood tests | UCD | Non-commercial: Academic |
| Reward | Changes in rewared and appetitive behaviour in patients who have lost >10% of their body weight after undergoing curative surgery for oesophageal cancer | Observational with radiology or blood tests | Irish Cancer Society | Charity |
| Sublimity CYC-202 | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severly Active Ulcerative Colitis | Clinical trial | Sublimity Therapeutics | Commercial: Industry |