Gastroenterology Trials

Clinical research is of fundamental importance to – and has a very strong foundation in – the National Centre for Paediatric Gastroenterology (NCPG), Children’s Health Ireland at Crumlin (CHI). The NCPG is in a unique position to capture the national cohort of children with inflammatory bowel diseases (IBD). IBD is a chronic inflammatory condition of the gastrointestinal tract that currently lacks a cure. IBD research is of great importance as the incidence in Ireland is increasing, mirroring that of the Western world. Prof. Séamus Hussey, Consultant Paediatric Gastroenterologist, leads the clinical research studies of inflammatory bowel diseases at the NCRC and CHI at Crumlin.

Clinical research in this department is carried out by Dr. Sarah Cooper, Clinical Research Coordinator, Ms Ilona Csizmadia and Dr Lenin Ekpotu, Research Assistants. Dr. Cooper, Ms Csizmadia and Dr. Ekpotu support numerous IBD research projects that stem from DOCHAS  (Determinants and Outcomes in Children and Adolescents with IBD). By the end of October 2018 over 850 children had been recruited to the study since 2012.

The NCRC is a national site for several international research studies with lead sites in Israel and Canada for example. These studies include:
– the genetics, environment and microbiology of CD (The GEM project),
– the efficacy and safety of vedolizumab in a paediatric population (The VedoKids Study),
– the efficacy and safety of adalimumab in a paediatric population with CD (The CAPE registry),
– the genetics of early onset IBD (the iNEOPICS study),
– the study of exclusive enteral nutrition (EEN) in combination with a specialised diet as an alternative to EEN alone in treating CD (the M-EEN study)
– developing a patient-reported outcome score for UC (Tummy-UC) and CD (Tummy- CD)

The paediatric gastroenterology department and the research team coordinate to allow the recruitment and 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