Gastroenterology Research Connecticut Children’s is among the most active in the country for basic, clinical and translational research. Our nationally recognized gastroenterologists lead and collaborate on over 25 IRB-approved studies, including NIH- and privately-funded digestive diseases research projects as well as clinical trials. Studies Open for Enrollment Open-label induction and maintenance study of oral cp-690,550 (tofacitinib) in children with moderately to severely active ulcerative colitis (OVATION) Sponsor: Pfizer Summary: This study is to evaluate the efficacy, safety and pharmacokinetics of tofacitinib in pediatric participants with moderately to severely active ulcerative colitis (UC). Site Principal Investigator: Jeffrey Hyams, MD Key eligibility: Ages 2-17 with moderately to severely active UC, failed anti-TNF treatment Dosing and Pilot Efficacy of 2′-Fucosyllactose in Inflammatory Bowel Disease Sponsor: NIH/NICHD through Cincinnati Children’s Hospital Medical Center Site Principal Investigator: Jeffrey Hyams, MD Summary: This study will assess the safety, tolerability, and efficacy of a prebiotic in promoting the growth of beneficial intestinal bacteria in children and young adults with inflammatory bowel disease (IBD) in stable remission on anti-TNF therapy. Key eligibility: Phase I will enroll participants aged 18-25 with IBD in remission on a stable dose of anti-TNF A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy Sponsor: Bristol-Myers Squibb Summary: This study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodyamics of Ozanimod in pediatric participants with moderately to severely active UC. Site Principal Investigator: Jeffrey Hyams, MD Key eligibility: Ages 2-17 with moderately to severely active UC, inadequate response, loss of response to, or intolerance to conventional therapies Development and evaluation of the TUMMY CD-index: A Patient Reported Signs and Symptom Index for Pediatric Crohn’s Disease Sponsor: IWK Health Centre Site Principal Investigator: Jeffrey Hyams, MD Summary: This study aims to develop a pediatric patient reported outcome tool that is valid and reliable to assess symptoms and disease activity for pediatric CD. Key eligibility: Patients aged 4-17 with CD and their caregivers Selected Studies in Follow-up (Not Enrolling): I6T-MC-AMAZ: A master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn’s disease Sponsor: Eli Lilly and Company Summary: This study is designed to evaluate the long-term efficacy of mirikizumab in pediatric participants with IBD. Site Principal Investigator: Jeffrey Hyams, MD A Longitudinal Observational Study of Patients with Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD) Sponsor: Target PharmaSolutions Site Principal Investigator: Karan Emerick, MD Summary: This is a 5-year, international, longitudinal, observational study of patients with nonalcoholic fatty liver disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. Precision Crohn’s Disease Management Utilizing Predictive Protein Panels (ENvISION) Sponsor: Helmsley Charitable Trust, through Cincinnati Children’s Hospital Medical Center Site Principal Investigator: Jeffrey Hyams, MD Summary: The goal of this study is to develop a blood test that accurately predicts the probability of deep remission with anti-TNF treatment, and a protein biomarker panel that distinguishes endoscopic mucosal healing from active intestinal inflammation in patients with CD. Predicting response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (VEDOKIDS) Sponsor: Shaare Zedek Medical Center Site Principal Investigator: Jeffrey Hyams, MD Summary: This study aims to prospectively explore the short term and long term outcomes of treatment with vedolizumab in a pediatric population, and to develop a prediction model for treatment success. DEVELOP Registry: A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease Sponsor: Janssen Site Principal Investigator: Jeffrey Hyams, MD Summary: The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with IBD, particularly in association with infliximab and other prescribed IBD therapies. A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn’s Disease (CD) – CAPE Sponsor: Abbvie Site Principal Investigator: Jeffrey Hyams, MD Summary: This is a global, multicenter, non-interventional registry of pediatric patients with moderately to severely active CD treated in a routine clinical setting with Humira or other immunosuppressant therapy. Pathogenic Heterogeneity in Mucosal Stem Cells in Pediatric Crohn’s Disease Sponsor: NIH, through the University of Houston Site Principal Investigator: Jeffrey Hyams, MD Summary: The focus of this study is to assess the adult stem cell profile of biopsies taken from patients with active Crohn’s disease (CD) and corresponding biopsies after they achieve clinical remission. For more information or questions, please e-mail GIResearch@connecticutchildrens.org
