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 UCDAcademic
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 TrialAbbVieIndustry
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 TrialAbbVieIndustry
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 TrialGilead SciencesIndustry
DIVERSITY OLEA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s DiseaseClinical TrialGilead SciencesIndustry
Sublimity CYC-202A 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 ColitisClinical TrialSublimity TherapeuticsIndustry
N/APharmacogenomic markers of biologic therapy outcome in Inflammatory Bowel DiseaseObservational studyINITIativeAcademic
N/AHuman colonic tissue ex-plants explants as precision medicine tools in Inflammatory Bowel DiseaseObservational studyN/AAcademic
GMI-IBDThe Genomic Basis of Inflammatory Bowel Disease (IBD) in Ireland – St. James HospitalObservational study with blood testsGenuity ScienceCommercial: Industry
Past Trials & Studies
Study NameStudy TitleStudy TypeSponsorSponsor Type
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