Research

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. The CAMEO Study: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed with Crohn’s Disease
   Sponsor: National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK, 1U01DK134356-01)
   Site Principal Investigator: Victoria Grossi, MD
   Summary: The purpose of CAMEO is to help us identify clinical, radiologic, genomic, immune, microbial, and transcriptomic factors associated with complete intestinal healing in children with Crohn’s disease treated with a common form of therapy (anti-TNF biologics).
   Key eligibility: Children ages 6-17 who will be undergoing diagnostic studies for a possible diagnosis of Crohn’s disease
    
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: Patients ages 18-25 with IBD in remission on a stable dose of anti-TNF
    

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.

   

• 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 [at] connecticutchildrens.org (GIResearch[at]connecticutchildrens[dot]org)