Gastroenterology Trials

Clinical research is of fundamental importance to many departments within Our Lady’s Children’s Hospital, Crumlin (OLCHC); in particular, clinical research has a very strong foundation in the Department of Gastroenterology, Hepatology and Nutrition lead by Dr. Seamus Hussey, Consultant Paediatric Gastroenterologist. Dr. Hussey dedicates his academic research time to the study of Inflammatory Bowel Disease (IBD).

The Gastroenterology department in OLCHC is the National Centre for Paediatric Gastroenterology in Ireland, therefore OLCHC is in a unique position to capture a national cohort of Children with IBD. IBD is a chronic inflammatory condition of the gastrointestinal tract and is an immune-mediated condition that comprises of Crohn’s disease (CD), ulcerative colitis (UC), and inflammatory bowel disease-unclassified (IBD-U). IBD-U is a form of colonic IBD whose diagnostic features do not allow colitis of CD or colitis of UC to be distinguished. Research surrounding IBD is of great importance as the incidence in Ireland is increasing, and this increase in mirrored in the Western world.

Clinical research in this department is carried out by Dr. Sadhbh O’Neill, Clinical Research Coordinator and Ms Alison O’Sullivan, Research Assistant. Dr O’Neill and Ms O’Sullivan progress numerous IBD research projects including DOCHAS (Determinants and Outcomes in Children and Adolescents with IBD). DOCHAS was established in January 2012 and seeks to identify and recruit all children diagnosed with IBD in Ireland. By the end of December 2017 over 750 children had been recruited to the study. Each year approximately 100 new patients are recruited to the study. The aim of the study is to determine why IBD incidence is increasing in an Irish population and to determine the outcomes for children diagnosed with IBD.

As IBD incidence is increasing world-wide we are involved in a number of international research studies which have lead sites in Israel and Canada. These studies are investigating many factors associated with IBD including the study of genetics in CD (The GEM project), the efficacy and safety of the drug Vedolizumab in a paediatric population (The VedoKids Study), the efficacy and safety of another drug Humira in a paediatric population with CD (The CAPE registry), the study of early onset IBD (the iNEOPICS study), the potential of exclusive enteral nutrition (EEN) in combination with a strict diet as an alternative to EEN alone as a treatment for CD (The Modified-EEN study) and finally two similar studies which aim to generate new indices that assess the activity of UC and CD over time. These new indices would be patient/parent reported and would assess the signs and symptoms of UC and CD (The TUMMY-UC and TUMMY-CD studies).

Clinical research is vital to the understanding of IBD and for the development of new medications to treat IBD. In OLCHC the Gastroenterology Department and the research team coordinate to allow the collection of the valuable data that will ultimately benefit patients and their parents.

Current Trials & Studies

Study NameStudy TitleStudy TypeSponsorSponsor Type
DOCHASDeterminants and Outcomes in Children and Adolescents with IBDNon-Interventional StudyNCRCAcademic - Investigator Led
Oral MicrobiomeThe oral microbiome in Children with New-Onset IBDNon-Interventional Studyn/aAcademic - Investigator Led
TUMMY UCPatient Reported Outcomes in Paediatric Ulcerative Colitis StudyNon-Interventional StudyIzaak Walton Killam Health CentreAcademic - Investigator Led
CAPEA Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (Adalimumab) in Paediatric Patients With Moderately to Severely Active Crohn's DiseaseNon-Interventional Clinical TrialAbbVieIndustry Sponsored
GEMA Multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel disease (IBD)Non-Interventional StudyMount Sinai HospitalAcademic - Investigator Led
M-EENModified Exclusive Enteral Nutrition with the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and RebiosisNon-Interventional Clinical TrialWolfson Medical CenterAcademic - Collaborative Group
iNEOPICSThe interNational Early Onset Paediatric IBD Cohort StudyNon-Interventional StudyThe Hospital For Sick Children TorontoAcademic - Collaborative Group
TUMMY CDPatient Reported Outcomes in Paediatric Crohns Disease StudyNon-Interventional StudyIzaak Walton Killam Health Centre, HalifaxAcademic - Investigator Led
VEDOKIDS studyPredicting response to Vedolizumab in Pediatric Inflammatory Bowel Diseases including drug levels: a multi‐center prospective Pan‐ European cohort study (P‐ECCO and ESPGHAN)Non-Interventional StudyESPHGANAcademic - Collaborative Group
CFLDThe Natural History of Cystic Fibrosis Liver Disease- Refining the PhenotypeNon-Interventional StudyHealth Research BoardAcademic - Investigator Led

Past Trials & Studies

Study NameStudy TitleStudy TypeSponsorSponsor Type
ASCAn investigation as to whether Infliximab has changed the national history of Acute Severe ColitisNon-Interventional Studyn/aAcademic - Investigator Led
RAPID IBDRetrospective study on pharmacokinetic infliximab data in young IBD patientsNon-Interventional Studyn/aAcademic - Investigator Led
EoEEstablishing the national incidence and prevalence of Eosinophilic Oesphagitis in Ireland over the last ten years and a description of its natural historyNon-Interventional Studyn/aAcademic - Investigator Led
GROWTH CD StudyGrowth Study: Factors predicting relapse and adverse outcomes early in newly diagnosed paed' Crohn Disease a prospective, multi centre prognostication study by the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) ‘Porto’ GroupNon-Interventional StudyESPHGANAcademic - Collaborative Group