Connecticut Children’s is among the most active pediatric health systems 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

  1. 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

     

  2. 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

     

  3. 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

     

  4. 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)

For more information or questions, please e-mail GIResearch [at] connecticutchildrens.org (GIResearch[at]connecticutchildrens[dot]org)