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.

Current Trials & Studies
Study NameStudy TitleStudy typeSponsorSponsor Type
GOAL-ARCGolimumab dose Optimisation to adequate levels to achieve response in ColitisClinical trial (NCT02687724) (2015-004724-62)UCDAcademic
Abbvie OLE M14-533A 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)AbbVieIndustry
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 B Rehabilitation Strategies following Oesophagogastric and Hepatopancreaticobiliary Cancer: ReStOreII - A Randomised Controlled Trial Observational with radiology or blood tests National (Government agency)
Past Trials & Studies
Study NameStudy TitleStudy TypeSponsorSponsor Type
GMI-IBDThe Genomic Basis of Inflammatory Bowel Disease (IBD) in Ireland – St. James HospitalObservational study with blood testsGenuity ScienceCommercial: Industry
DIVERSITY OLEA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s DiseaseClinical trial (NCT02914561)(2016-002763-34)Gilead SciencesIndustry
DIVERSITYCombined 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 DiseaseClinical trial (NCT02914600)(2016-001367-36)Gilead SciencesIndustry
Abbvie UCA 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 ColitisClinical Trial (NCT02819635) (2016-000641-31)AbbVieIndustry
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
N/AHuman colonic tissue ex-plants explants as precision medicine tools in Inflammatory Bowel DiseaseObservational studyN/AAcademic
N/APharmacogenomic markers of biologic therapy outcome in Inflammatory Bowel DiseaseObservational studyINITIativeAcademic
ReStOre at Home Rehabilitation Strategies following Oesophagogastric and Hepatopancreaticobiliary Cancer: ReStOreII - A Randomised Controlled Trial Observational with radiology or blood tests National (Government agency)
Clarinet ForteEfficacy 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 daysClinical trialIPSENIndustry
GEM ProjectA multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel DiseaseObservational-non invasiveN/AAcademic
PouchitisA Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic, Antibiotic Refractory Primary Idiopathic PouchitisClinical trialAtlantic PharmaceuticalsIndustry
MOBIDICMolecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC)Detection study In Crohn's disease patients (MOBIDIC) Version ModificationObservational with radiology or blood testsFrench Research ConsortiumIndustry
N/ABiomarkers and Drug Pharmacokinetic Factors Associated with Vedolizumab Therapy Outcome in Inflammatory Bowel DiseaseProspective observational studyN/AAcademic
REMINETA 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 treatmentClinical trialFrench Research ConsortiumAcademic
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