Research is critical in continuing to improve the care of children and adolescents with inflammatory bowel disease. Current research activities include clinical drug trials and studies examining the psychosocial effects of chronic diseases such as inflammatory bowel disease. The center also participates in multiple national and international IBD research cohorts which are being used in the ongoing effort to improve the treatment and quality of life for all those with IBD. Current studies include:
Impact of a Biofeedback Intervention on Microbiome, Metabolome and Clinical Outcomes in Pediatric IBD: Aims to determine whether stress reduction through biofeedback therapy effects disease activity, symptoms, stress, depression, quality of life, stress-related changes in the microbiome and metabolome.
Peer Mentoring to Improve Self-Management in Youth with IBD: Multicenter randomized controlled trial to evaluating a multifaceted peer mentoring program to improve quality of life and health outcomes compared to an educational activity program
Precision Crohn’s Disease Management Utilizing Predictive Protein Panels (ENVISION): Aims to identify proteins predicting favorable outcomes for patients initiating anti-TNF therapies.
Intestinal Disease Biobank: Genetic, Functional, and Microbial Studies in Intestinal Disease (NEOPICS): Biobanking of biological specimens from patients with very early onset of inflammatory bowel disease diagnosed at 6 years old or under to identify applicable genes to improve diagnosis, predict treatment response and impact long-term outcomes.
Blood and Stool Molecular Biomarkers detection study in pediatric Crohn’s Disease Patients Study (Prometheus): The objective of this study is to evaluate the effectiveness of the Prometheus Monitr Test to predict disease status in pediatric Crohn’s disease patients.
Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn’s Disease (RISK): Multicenter observational study designed to validate a risk stratification model for predicting severe and complicated disease phenotype in children with Crohn’s disease (CD).
Predicting Response to standardized Pediatric Colitis Therapy (PROTECT): Multicenter open-label study evaluating the safety and efficacy of standardized initial therapy using either mesalamine or corticosteroids then mesalamine for the treatment of children and adolescents newly diagnosed with ulcerative colitis.
Pharmacodynamic Targets to Enrich Personalized Anti-TNF Dosing Study (RADAR): Multicenter cross-sectional study aims to identify biochemical and drug concentration targets for pediatric Crohn’s Disease treatment response to anti-TNF therapy.
A Randomized, Double-Blind, Placebo-controlled, Multi-center Pragmatic Clinical Trial to Evaluate the Effectiveness of Low Dose Oral Methotrexate in Patients with Pediatric Crohn’s Disease Initiating Anti-TNF Therapy (COMBINE): Multicenter randomized controlled trial to determine whether the addition of low-dose oral methotrexate (MTX) leads to better outcome in children with Crohn’s disease (CD) initiating anti-TNF therapy compared to children treated with monotherapy
Clinical and Molecular Signature to Predict Response to Biologic Therapy in Pediatric IBD: A Multicenter Observational study targeting The Inflammatory Signature to Personalize Biologics in Pediatric IBD (REFINE): Multicenter observational study aims to identify biomarkers of treatment response to infliximab and vedolizumab in children with IBD.
Anti-TNF Therapy for Refractory Colitis in Hospitalized Children (ARCH): Multicenter observational study investigating factors predicting early clinical response in hospitalized children with severe steroid-refractory ulcerative colitis or inflammatory bowel disease-unclassified.
Using patient data to transform care and improve outcomes for children, adolescents, and young adults with Inflammatory Bowel Disease: The ICN Registry Study: Multicenter registry database captures clinical data to support better clinical care, quality improvement efforts and assess changes in the clinical outcomes of children with IBD.
Understanding the Impact of Telemedicine on IBD Care: This project explores the impact of telemedicine upon the care delivered to patients with IBD, including access to care and MyChart use.
Pediatric Prospective on Biosimilars and Non-Medical Switches in Pediatric Inflammatory Bowel Disease: This project evaluates pediatric patients and their guardian’s perception on biosimilars and non-medical switches in inflammatory bowel disease patients.
Assessing multidisciplinary provider perspectives on medical decision-making and education related to ostomy surgery in pediatric patients with IBD: This study aims to understand how multidisciplinary provider coordinate and collaborate on medical decision-making and education related to ostomy surgery for pediatric patients with IBD, as well as identify barriers and recommendations for improved coordination and collaboration for this population.
Understanding Pediatric GI Providers’ Perceptions of and Engagement with Psychosocial Professionals: This study seeks to understand pediatric GI providers’ perceptions of and engagement with psychosocial professionals (e.g., social work, psychology).
Redefining Health Systems: Hardships, Barriers, and Potential Interventions in Pediatric Inflammatory Bowel Disease: Barriers and Solutions in IBD Study: This prospective longitudinal study assesses health systems and related barriers from the patient, family, and provider’s perspective, and access potential personalized healthcare system solutions to the identified barriers.
A Data-Driven Approach for Risk Stratification and Outcome Prediction for Pediatric Inflammatory Bowel Disease Study: The Data Linkage Study: This study will build a risk prediction model for pediatric Inflammatory Bowel Disease (IBD) to predict patient outcomes and facilitate efficient decision support for personalized care. Specifically, aim to develop a machine-learning based clinical pathway learning algorithm for pediatric IBD that predicts for 3 outcomes of interests: (1) sustained remission/flare, (2) surgery, and (3) hospitalization.
Relation of Social Factors with Racial Disparities in Pediatric Inflammatory Bowel Disease: The SaFR Kids Study: This cross-sectional study compares social constructs including household income, parental health literacy, parental distrust in the healthcare system, and time needed to travel to see an IBD specialist among children of different race and ethnic groups within the United States.
Assessing Post-operative Recurrence in Pediatric Crohn’s Disease: Aims to determine post-operative recurrence in children with Crohn’s Disease and evaluate potential risk factors that influence disease course following surgical intervention.
Assessing the Durability of Anti-TNF Medications in Pediatric IBD: Evaluating the risks of loss of response to anti-TNF medications in pediatric IBD and potential risk factors.
Long term outcomes using nutrition therapy in pediatric Crohn's disease: This retrospective review evaluates 6- and 12-month outcomes for patients with Crohn's disease treated with nutrition therapy in the induction and maintenance phases.
Retrospective Cohort Study of Very Early Onset IBD: (VEOIBD): This multicenter study will describe the clinical and phenotypic characteristics of very early onset inflammatory bowel disease (VEOIBD) at presentation and the use and outcomes of medical and surgical therapies among patients with inflammatory bowel disease before the age of six years old.